GSS 6.

0 AND ™

AnyPlus 5.5 ®

Pedicle Screw Systems

Surgical Technique Guide

Comprehensive posterior
pedicle screw systems for
stabilizing the thoracic,
lumbar and sacral spine.
GSMedicleUSA.com
 Welcome to GS Medical USA
and the GSS™ 6.0 and AnyPlus®
GSS 6.0 ™
AND 5.5 Pedicle Screw Systems. Our
AnyPlus 5.5
goal at GS Medical is to offer
®
cost‐contained products
Pedicle Screw Systems with superior quality that
provide innovative solutions
for spine surgeons and their patient’s needs. The GSS™
6.0 and AnyPlus® 5.5 Pedicle Screw systems follow this
ideology, and were developed to provide the surgeon
with a comprehensive, state‐of‐the‐art system for
stabilizing the thoracic, lumbar and sacral spine.

There are several key differentiating features and All implants are made of TI‐6AI‐AV (ASTM F1 36‐98),
benefits one will find within these systems including, and are combined with biomechanical properties
but not limited to: for advanced strength, stability and MRI scan
compatibility.
• Unique buttress‐style cylindrical thread design
optimizes a solid screw purchase to the vertebral It is our goal at GS Medical to continue to render
bodies and pedicles new technology, whereby surgeons have a
• Polyaxial screw head has a wide 40 Degree complete system for addressing degenerative
range of motion to position screw head and thoracic, lumbar and sacral spinal conditions.
adjust in multiple planes for ease of insertion The following surgical technique guide provides a
sequential delineation of the product(s) and their
• Ample variety of screw diameter and lengths use within the surgical setting, as well as a complete
available to meet surgeon preference and listing of the accompanying instrumentation.
address any patient anatomical variants
encountered by the surgeon
• Monoaxial screw option
• Reduction screw option
• Crosslink option

GSS™is a Trademark of GS Medical Company, Ltd. AnyPlus® is a Registered Trademark of GS Medical Company, Ltd. ©Copyright 2015, GS Medical Company, Ltd. Caution: Federal Law (USA)
restricts these devices for sale by or on the order of a physician. The surgical technique described hereafter in this surgical technique guide is considered standard use by the manufacturer,
GS Medical, Ltd. The guide is put forth as a recommendation and should be used in tandem with the surgical knowledge of the surgeon. For additional information on the products listed in
this guide, please contact the GS Medical Customer Service Department: GS Medical USA, Attn: Customer Service, 6 Wrigley, Irvine, CA 92618, Office: 866-904-8144, www.gsmedicalusa.com
GSS 6.0 AND
™

AnyPlus 5.5 ®

Pedicle Screw Systems Table of Contents

Intended Use
Differentiating Features between the GSS™ 6.0 &
AnyPlus® 5.5 Pedicle Screw Systems

Surgical Technique Steps

Step 1: Patient Positioning & Incision.................. 4
Step 2: Standard Operative Exposure
of Bony Landmarks.......................................... 4
Step 3: Pedicle Identification & Preparation....... 5
Step 4: Screw Length Determination and
Screwdriver Assembly...................................... 6
Step 5: Screw Insertion......................................... 8
Step 6: Rod Contour and
Length Determination..................................... 9
Step 7: Rod Application – Placement................. 9
Step 8: Locking Set Screw Insertion................... 10
Step 9: Rod Reduction (optional)..................... 10
Step 9: Rod Reduction....................................... 11
Step 10: Compression and/or Distraction........ 13
Step 11: Deformity Correction............................ 14
Step 12: Final Tightening.................................... 15
Step 13: Connector Application........................ 16
Step 14: Unlocking and Removal Technique.... 16

Product Catalog
Product Catalog............................................... 17
GSS™ 6.0 Implants............................................ 18
AnyPlus® 5.5 Implants....................................... 20
instruments........................................................ 23
Instrument Cleaning, Care
and Handling Policies.................................. 25
Important Information on the
AnyPlus® & GSS™ Spinal Systems................ 26

GS Medical 1
Intended Use
The GSS™ and AnyPlus® Pedicle Screw Systems
are non-cervical spinal fixation systems and
were developed to provide surgeons with
straightforward, well-designed, comprehensive
implant options to accommodate anatomical
patient variations, and to address a myriad of
spinal disorders. The following list identifies
indications and contraindications for
appropriate use of the GSS™ and AnyPlus® Pedicle
Screw Systems.

Indications
(when fusion is necessary for any or all of the
following spinal conditions):

• Degenerative disc disease (DDD) as defined

by back pain of discogenic origin with
degeneration of the disc confirmed by patient
history and radiographic studies;
• Spinal Stenosis;
• Disc herniation;
• Tumor;
• Isthmic Spondylolisthesis;
• Trauma: (i.e., fractures or dislocation);
• Deformities or curvatures (i.e., Scoliosis,
Hyper-Kyphosis or Hypo-Kyphosis);
• Degenerative Spondylolisthesis;
• Pseudoarthrosis

This is intended as a guide only. There are multiple techniques for the insertion of pedicle screws and, as with any surgical procedure, a surgeon should be thoroughly trained before
proceeding (should only be performed after thorough training on instrumentation). Each surgeon must consider the particular needs of the patient and make the appropriate adjustments
when necessary and as required. Please refer to the instructions for each insert for complete system descriptions, indications and warning. Additional questions should be directed to GS
Medical USA, 1-866-904-8144.

2 GS Medical
Differentiating Features
Between the GSS™ 6.0 & AnyPlus®
5.5 Pedicle Screw Systems
In order to efficiently meet the needs of our surgeons The following key instruments should be kept
we have created this technique guide combining separate:
the GSS™ 6.0 & AnyPlus® 5.5 Pedicle Screw Systems • Screw drivers
steps of use.
• Rods
The GSS 6.0 & AnyPlus 5.5 Pedicle Screw Systems
™ ®
• Pedicle screws
are not interchangeable. The instrumentation in
• Set screws
each of the sets has been specifically designed to
accommodate the 5.5mm and 6.0mm rods and • Rod holders
screws. The corresponding instruments should only • Rod reduction sheaths
be used with the designated sets.
• Rod rocker
• In-Situ Benders

5.5 Anyplus Screw/Driver Interface 6.0 GSS Screw/Driver Interface

• Secure cross pattern • Strong three prong screw

screw driver to tulip head driver to tulip head
interface interface
• Specifically designed to • Specifically designed to
accommodate 5.5mm rod accommodate 6.0mm rod
• Set screws can be used • Set screws only work with
with AnyPlus or AnyPlus NX GSS Pedicle Screws
Systems

GS Medical 3
Surgical Technique Steps 1 2
Step 1
Patient Positioning &
Incision
Place patient prone on radiolucent operating table
and verify correct anatomical spinal alignment.
Position the patient on operating table of choice
(pads, frame, gel rolls) to allow for appropriate
physiologic lumbar lordosis and thoracic kyphosis.
Next locate appropriate operative levels by
referencing radiographic images or topographical
landmarks and mark intended incision. After skin
prep apply sterile drapes around incision site and
make incision.

Step 2
Standard Operative
Exposure of Bony
Landmarks
Perform subperiosteal dissection to expose bony
elements where fusion will occur.

4 GS Medical
Surgical Technique Steps 3
Step 3
Pedicle Identification &
Preparation
Locate the pedicle landmark and use GSS Awl
to breach the bony cortex. Remove the GSS Awl
and insert the GSS Probe or Thoracic Bone Probe
to identify the pedicle canal. Once exposed, the
Ball Tip Tester can be inserted to confirm pedicle
integrity, orientation and depth.

Optional: Taps, corresponding to available screw

sizes, may be used to further prepare the pedicle
depending upon surgeon preference and bone
quality. GS Medical screws are self-tapping and
may eliminate the need to use the Tap, unless bone
structure is very dense. Please note that the taps
0.5mm undersized

Instruments used:
Curved Thoracic Bone Probe, Straight Thoracic Bone Probe,
GSS Probe (Curved), GSS Probe (Straight), GSS Awl,
Ball Tip Tester, Tap 4.5mm, Tap 5.5mm, Tap 6.5mm, Tap 7.5mm,
Tap 8.5mm
Straight Thoracic Bone Probe
Curved Thoracic Bone Probe

#GS110-0326 (6.0) or (5.5)

#GS110-0327 (6.0) or (5.5)

#GS110-0216 (6.0) or (5.5)

#GS110-0316 (6.0) or (5.5)
#GS110-0317 (6.0) or (5.5)

GSS Probe (Straight)

GSS Probe (Curved)

Ball Tip Tester

#GS110-0548

#GS110-0558

#GS110-0568

#GS110-0588
#GS110-0578
#GS110-0416

Tap 4.5mm

Tap 5.5mm

Tap 6.5mm

Tap 8.5mm
Tap 7.5mm
GSS Awl

GS Medical 5
Surgical Technique Steps 4
Step 4
Screw Length
Determination and
Screwdriver Assembly
The Pedicle Probe comes equipped with depth
markers along the insertion shaft and can be used
to determine appropriate screw length. Once screw
length is confirmed, load selected implant onto Poly
Screw Driver Shaft and attach preferred handle.
Loading of the screw is easiest from the screw caddy.
Always measure screw sizes before implanting.
Once assembled, insert screw into prepared pedicle
pathway.

Note: GS Medical screw caddy’s come equipped

with built-in measuring blocks.

Instruments used:
Ball Tip Tester, Poly Reduction Screw Driver , Mono Screw Driver, Ratcheting T-Handle, Ratcheting Straight Handle
#GS110-0828 (5.5) or GS GS110-0823 (6.0)
Reduction Poly Driver Shaft

GSS Poly Screw Driver Shaft

Ball Tip Tester #GS110-0416

Poly Screw Driver Shaft

Mono Screw Driver
#(5.5) GS110-0938

#(5.5) GS110-0928

#(6.0) GS110-0923

Ratcheting
#US114-3010
Ratcheting
#US110-1002

Straight
T-Handle

Handle

6 GS Medical
Surgical Technique Steps 4
Step 4 continued
Screwdriver and Screw
Assembly
Select poly Screwdriver shaft. Attach the Ratcheting
Straight Handle or Ratcheting T-Handle using the
forward/reverse collar to the Screwdriver shaft by
rotating in a clockwise direction. Align Screwdriver
with screw, engage screw head to tip of Screwdriver,
turn clockwise while applying firm pressure to secure
connection. Connection is secured by threading
the locking portion prongs of the Screwdriver into
3
the screw head and sliding the sleeve down the
Screwdriver shaft.

GS Medical 7
Surgical Technique Steps 5
Step 5
Screw Insertion
Insert screw into prepared pedicle pathway and Adjuster if necessary to align screw heads before
rotate Screwdriver clockwise to advance screw in proceeding. If reduction screws are implanted, use
the pedicle. Release Screwdriver by rotating the the Long Arm Tab Breakers to break off the long arm
sleeve counterclockwise. Repeat aforementioned extension tabs from the screw heads.
steps 3 and 4 for each level of screw insertion.
NOTE: If screw placement requires adjustment, use Surgeon should note that only after distraction/
the Screw Adjuster Shaft to raise or lower screw to compression, final screw and rod tightening is
appropriate dorsal height. Additionally, it is pertinent performed, should the long tabs be broken off.
that all screw heads align prior to rod application.
Surgeon may elect to use Poly Head Screw Optional: Radiograph or Neuromonitoring devices
can be used to confirm appropriate screw
placement prior to rod application.

Instruments used:
Poly Screw Driver, Mono Screw Driver, Poly Reduction Screw Driver, Poly Head Screw Adjuster,
Long Arm Tab Breakers and Screw adjuster shaft
#GS110-0828 (5.5) or GS #GS110-0823 (6.0)

#GS110-3011 (6.0) or #GS110-3016 (5.5)

#GS110-1110 (6.0) and GS110-1106 (5.5)

Long Arm Tab Breakers #GS110-1416
Reduction Poly Driver Shaft

Poly Head Screw Adjuster

Poly Screw Driver Shaft
GSS Poly Screw Driver

Screw Adjuster Shaft

Mono Screw Driver
(5.5) #GS110-0928
(6.0) #GS110-0923

#(5.5) GS110-0938

8 GS Medical
Surgical Technique Steps 6 7
Step 6 Step 7
Rod Contour and Length Rod Application –
Determination Placement
Select appropriate rod length to span construct. The Poly Head Screw Adjuster can be used to align
Rods are available in both straight and contoured screw heads prior to insertion of the rod. Grasp the
options. If rod requires further contouring, use rod using the Ring-Handle Rod Holder, position rod
the French Rod Bender to bend rod to desired in screw heads and seat fully into screw.
curvature. Additionally, French Rod Bender has an
adjustment wheel to measure for rod diameter. Note: GS Medical rods come premarked with a
longitudinal rod marking along the vertical axis.
Optional: The In-Situ Bender instruments are This rod marking will allow the surgeon to align GS
available, specified left or right approach, if the Medical’s French Bender accordingly, and assist the
rod needs contouring and is already partially or surgeon with multi-planer rod contouring.
fully seated in screw heads.

Optional: Rod template available for purchase, not

included in standard set.

Instruments used:
Poly Head Screw Adjuster, French Bender, In-Situ Bender (LFT) 6.0 or 5.5, In-Situ Bender (RGT)6.0 or 5.5,
6.0 mm Rod Template, 5.5 mm Rod Template

#GS110-3011 (6.0) #GS1103016 (5.5)

Poly Head Screw Adjuster
French Bender GS110-1526

#GS110-1536 (6.0) and

5.5 mm Rod template

6.0 mm Rod template
In-Situ Bender (LFT)

#GS110-1546 (6.0) or
In-Situ Bender (RGT)
#GS110-1537 (5.5)

#GS110-1547 (5.5)

GS Medical 9
Surgical Technique Steps 8 9
Step 8
Locking Set Screw Insertion
Attach set screw to Set Screw Starter. The set screw driver with direct downward pressure. Align Set Screw
is securely loaded onto set screw starter by placing Starter assembly axially with screw head and turn
the set screw onto a flat surface and engaging with clockwise to engage locking set screw.

Set Screw Starter

Step 9
Rod Reduction
If additional reduction is necessary, GS Medical Note: GS Medical offers the Rod Gripper, which can
offers four options for rod reduction. These include; be special ordered from our Deformity Set, and can
the Rod Pusher, Rod Rocker, Kerrison Persuader, and assist the surgeon with more robust rod reductions.
the Rod Reduction Sheath.

Instruments used:
Rod Rocker, Power Rod gripper, Set Screw Starter, Kerrison Persuader 5.5 and 6.0, Rod Reduction Sheath 5.5, Ring Handle
Rod Holder 6.0 or 5.5, Rod Pusher 6.0 and 5.5
#GS110-1216 (6.0) or #GS110-1220 (5.5)

Set Screw Starter #GS110-2312 (6.0)

Rod Reduction sheath US110-3701

#GS110-1920 (6.0) or #GS110-1926
Power Rod Gripper #GS10-1311
Rod rocker #GS110-2210 (5.5)

#GS110-1716 (6.0) and (5.5)

Ring Handle Rod Holder

Kerisson persuader
or #GS110-2316 (5.5)

Rod Pusher

10 GS Medical
Rod Reduction Techniques 9
Step 9 continued
Rod Reduction
Rod Pusher (AnyPlus®)
Rod Pusher (AnyPlus®)
The Rod Pusher can be used when a minor gap
exists between the rod and screw tulip head. Simply
situate device on rod next to the tulip head of the
pedicle screw and apply downward pressure to seat
rod.

Rod Rocker (GSS™)

The Rod Rocker and AnyPlus® systems can also
be used for slight reductions to fully seat the rod.
The fork rounded ends fit over the lateral ridges on
the tulip head of the pedicle screws. Proceed with
reduction by pushing backward on the handle.
This motion positions the rod into the head of the
implant.
Rod Rocker (GSS™)

Kerrison Persuader
(Both systems)
The Kerrison Persuader is used for more substantial
reductions. To use the Kerrison Persuader, position
the instrument parallel to the rod and simultaneously
engage the rod and screw head by squeezing the
handles. When the desired amount of reduction
has been achieved, insert the set screw through the
Kerrison Persuader shaft using the Set Screw Starter.

Kerrison Persuader
(Both Systems)

GS Medical 11
Surgical Technique Steps 9
Step 9 continued
Rod Reduction Sheath (AnyPlus) the reducer sheath ring. This will lock the
Place the Reduction Sheath with attached tower onto the top of the pedicle screw.
handle over the head of the tulip. Ensure To complete reduction, turn the universal
the hinges of the tip of the reducer align handle clockwise until desired reduction
with the grooves on the tulip head of has been achieved. Slide up on reduction
the pedicle screw. Press downward on sheath ring to remove.

Step C

Step A

Step B

12 GS Medical
Surgical Technique Steps 10
Step 10
Compression and/or Distraction (If Indicated)
The Compressor allows the surgeon to approximate implants to be compressed, and finally squeezing
the pedicle screw implants. Compression can be the Compressor until the desired amount of
accomplished by locking one implant, placing the compression is achieved. Conversely, the Distractor
instrument on the caudal and cephalad ends of the allows the surgeon to increase distance between
implants. Affix the Distractor between the two screw
heads to be distracted and squeeze the instrument
until the desired level of distraction is accomplished.

Compression

Distraction

Instruments used: Compressor and Distractor

(5.5) and (6.0)

Compressor

(6.0) or (5.5)
#GS110-2716

#GS110-2816
Distractor

GS Medical 13
Surgical Technique Steps 11
Step 11
Deformity
Correction
(available by order as an optional additional
instrument set)

For additional options for deformity

correction GS medical offers an additional
set of implant and instrumentation options,
including; offset connectors, domino
connectors and axial connectors.

Offset connectors offer medial/lateral

adjustability. These open and closed
connectors are available in lengths of 15-
40mm (in 5mm increments).

Domino Connectors (closed), Domino

Connector (open), and Axial Connectors
allow for 5.5mm x 5.5mm, 6.0mm x 6.0mm,
6.0mm x 5.5mm, and 5.5mm x 6.0mm rod to
rod connections.

The Deformity Set comes standard with

straight rod sizes up to 500mm.

To assist in the contouring of rods the

deformity set offers the Power Rod Gripper
and the Rod Gripper.

Closed OPEN

14 GS Medical
Surgical Technique Steps 12
Step 12
Final Tightening
Final tightening is achieved by affixing the Anti-
Torque wrench to the tulip head of the pedicle
screw (either parallel or perpendicular to the rod).
The Torque Limiting Set Screw Driver is then inserted
into the Anti-Torque Wrench and 12 NM of pressure
is applied for final tightening. An audible double
click will be heard when final tightening has been
achieved.

Note: If reduction screws were implanted during

the procedure, make certain to break off screw
tabs and remove from surgical field prior to closing
the wound.

Note: Anti-Torque Wrench is appropriately

engaged when smaller opening is affixed around
rod.

Instruments used:
Anti-Torque Wrench, Torque Limiting Set Screw Driver
Torque Limiting Set Screw Driver
#TL131106 (6.0) or #US112-0610 (5.5)

Anti-Torque Wrench
#GS110-2916 (6.0) or
#GS110-2917 (5.5)

GS Medical 15
Surgical Technique Steps 13 14
Step 13
Connector Application Instruments used:

(If Necessary) Torque-Limiting T-Handle, Transverse Link

Driver (Starter), Transverse Link Driver (Final)

Cross Link
GS Medical transverse connectors come
pre-contoured, ready for implantation and
are arch-designed to accommodate bone
grafting. 5Nm (affix the 5Nm Torque

Torque-Limiting T-Handle #GS112-0610

Limiting T-Handle) on the Transverse
Link Driver (Starter). Use this instrument

Transverse Link Driver (Starter)

assembly to affix the crosslink to the

Transverse Link Driver (Final)

rod on each side of the construct.
Thereafter, secure and torque the
nut on one side of the crosslink,
and then the opposing side. Finally,
tighten the middle nut. At each step,

#GS110-3516

#GS110-3516
listen for the audible double click to ensure
cross connector is correctly tightened. The
Transverse Link Driver (Final) can be used as
a final tightening agent.
Connectors are adjustable and come in a variety
of lengths to accommodate patient anatomical
variations.

Instruments used:
Anti-Torque Wrench, Torque Limiting Set Screw Driver

Step 14
Unlocking and
Anti-Torque Wrench
#GS110-2916 (6.0)
#GS110-2917 (5.5)

Removal Technique
If it is necessary that any part of the construct
Torque Limiting Set Screw Driver

should need revision or removal, the Anti-Torque

Wrench and Set Screw Driver can be used to loosen
previously tightened locking set screws. Removal of
the system is performed by reversing the order of the
or #GS110-2443 (5.5)

implant procedure.
#TL131106 (6.0)

16 GS Medical
Product Catalog

GSS™ Implants
GSS™ Mono-Axial Pedicle Screw GSS™ Poly-Axial Pedicle Screw
DIAMETER 4.5mm DIAMETER 4.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
GS0101 - 4535 35 GS0102 - 4530 30
GS0101 - 4540 40 GS0102 - 4535 35
GS0101 - 4545 45 GS0102 - 4540 40
GS0101 - 4550 50 GS0102 - 4545 45
GS0102 - 4550 50
GSS™ Mono-Axial Pedicle Screw GS0102 - 4555 55
DIAMETER 5.5mm
GSS™ Poly-Axial Pedicle Screw
Catalog Number Length (mm) DIAMETER 5.5mm
GS0101 - 5520 20
GS0101 - 5525 25 Catalog Number Length (mm)
GS0101 - 5530 30 GS0102 - 5530 30
GS0101 - 5535 35 GS0102 - 5535 35
GS0101 - 5540 40 GS0102 - 5540 40
GS0101 - 5545 45 GS0102 - 5545 45
GS0101 - 5550 50 GS0102 - 5550 50
GS0101 - 5555 55 GS0102 - 5555 55
GS0101 - 5560 60
GSS™ Poly-Axial Pedicle Screw
GSS™ Mono-Axial Pedicle Screw DIAMETER 6.5mm
DIAMETER 6.5mm Catalog Number Length (mm)
Catalog Number Length (mm) GS0102 - 6530 30
GS0101 - 6530 30 GS0102 - 6535 35
GS0101 - 6535 35 GS0102 - 6540 40
GS0101 - 6540 40 GS0102 - 6545 45
GS0101 - 6545 45 GS0102 - 6550 50
GS0101 - 6550 50 GS0102 - 6555 55
GS0101 - 6555 55 GS0102 - 6560 60

GSS™ Mono-Axial Pedicle Screw GSS™ Poly-Axial Pedicle Screw

DIAMETER 7.5mm DIAMETER 7.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
GS0101 - 7520 20 GS0102 - 7530 30
GS0101 - 7525 25 GS0102 - 7535 35
GS0101 - 7530 30 GS0102 - 7540 40
GS0101 - 7535 35 GS0102 - 7545 45
GS0101 - 7540 40 GS0102 - 7550 50
GS0101 - 7545 45 GS0102 - 7555 55
GS0101 - 7550 50 GS0102 - 7560 60
GS0101 - 7555 55 GS0102 - 7565 65
GS0101 - 7565 60 GS0102 - 7570 70
GS0102 - 7575 75
GSS™ Mono-Axial Pedicle Screw GS0102 - 7580 80
DIAMETER 8.5mm GS0102 - 7590 90

Catalog Number Length (mm) GSS™ Poly-Axial Pedicle Screw

GS0101 - 8530 30 DIAMETER 8.5mm
GS0101 - 8535 35
GS0101 - 8540 40 Catalog Number Length (mm)
GS0101 - 8545 45 GS0102 - 8535 35
GS0101 - 8550 50 GS0102 - 8540 40
GS0101 - 8555 55 GS0102 - 8545 45
GS0102 - 8550 50
GSS™ Mono-Axial Pedicle Screw GS0102 - 8555 55
DIAMETER 9.5mm GS0102 - 8560 60
GS0102 - 8565 65
Catalog Number Length (mm) GS0102 - 8570 70
GS0101 - 9535 35 GS0102 - 8575 75
GS0101 - 9540 40 GS0102 - 8580 80
GS0101 - 9545 45 GS0102 - 8590 90
GS0101 - 9550 50
GS0101 - 9580 80
GS0101 - 9590 90

GS Medical 17
Product Catalog

GSS™ Implants
GSS™ Poly-Axial Reduction Screw GSS™ Set Screw DIAMETER 5.5mm
DIAMETER 4.5mm Catalog Number Length (mm)
Catalog Number Length (mm) GS0104 - 0010 10mm(0.D)X
GS0122 - 4525 25 5.3mm(H)
GS0122 - 4530 30
GS0122 - 4535 35
GS0122 - 4540 40
GS0122 - 4545 45

GSS™ Poly-Axial Reduction Screw GSS™ Transverse Connector (Version. 1)

DIAMETER 5.5mm Catalog Number Length (mm)
GS0120 - 0035 35
Catalog Number Length (mm) GS0120 - 0038 38
GS0122 - 5530 30 GS0120 - 0042 42
GS0122 - 5535 35 GS0120 - 0050 50
GS0122 - 5540 40
GS0122 - 5545 45
GS0122 - 5550 50
GS0122 - 5555 55
GS0122 - 5560 60
GSS™ Transverse Connector (Version. 3)
GSS™ Poly-Axial Reduction Screw Catalog Number Length (mm)
DIAMETER 6.5mm GS1306 - 6030 30
GS1306 - 6035 35
Catalog Number Length (mm) GS1306 - 6040 40
GS0122 - 6530 30 GS1306 - 6050 50
GS0122 - 6535 35
GS0122 - 6540 40
GS0122 - 6545 45
GS0122 - 6550 50
GS0122 - 6555 55
GS0122 - 6560 60

GSS™ Poly-Axial Reduction Screw

DIAMETER 7.5mm
Catalog Number Length (mm)
GS0122 - 7530 30
GS0122 - 7535 35
GS0122 - 7540 40
GS0122 - 7545 45
GS0122 - 7550 50
GS0122 - 7555 55
GS0122 - 7560 60

GSS™ Poly-Axial Reduction Screw

DIAMETER 8.5mm
Catalog Number Length (mm)
GS0122 - 8535 35
GS0122 - 8540 40
GS0122 - 8545 45
GS0122 - 8550 50

18 GS Medical
Product Catalog

GSS™ Implants
ACCESSORIES Lateral Rod Connector (Closed)
Catalog Number Length (mm)
Axial Rod Connector GS0192 - 0615 15
Catalog Number Length (mm) GS0192 - 0620 20
GS0190 - 6060 11mm (0.D) X GS0192 - 0625 25
29(L) GS0192 - 0630 30
GS0192 - 0635 35
GS0192 - 0640 40

Lateral Rod Connector (Open)

Catalog Number Length (mm)
GS0193 - 0610 28
Domino Rod Connector GS0193 - 0615 33
GS0193 - 0620 38
Catalog Number Length (mm) GS0193 - 0625 43
GS0195 - 6060 10mm(0.D)X GS0193 - 0630 48
14(L)X11.5(H) GS0193 - 0635 53
GS0193 - 0640 58

GSS™ Straight Rod DIAMETER 6.0mm

Catalog Number Length (mm)
GS0150 - 0040 40
GS0150 - 0050 50
GS0150 - 0060 60
GS0150 - 0070 70
GS0150 - 0080 80
GS0150 - 0090 90
GS0150 - 0100 100
GS0150 - 0110 110
GS0150 - 0120 120
GS0150 - 0130 130
GS0150 - 0140 140
GS0150 - 0150 150
GS0150 - 0160 160
GS0150 - 0170 170
GS0150 - 0180 180
GS0150 - 0190 190
GS0150 - 0200 200
GS0150 - 0250 250
GS0150 - 0300 300
GS0150 - 0350 350
GS0150 - 0400 400
GS0150 - 0500 500
GS0150 - 0600 600

GSS™ Rod Prebent DIAMETER 6.0mm

Catalog Number Length (mm)
GS0160 - 0035 35
GS0160 - 0040 40
GS0160 - 0050 60
GS0160 - 0060 60
GS0160 - 0070 70
GS0160 - 0080 80
GS0160 - 0090 90
GS0160 - 0100 100
GS0160 - 0110 110
GS0160 - 0120 120

GS Medical 19
Product Catalog

AnyPlus® 5.5 Implants

AnyPlus® Mono-Axial Pedicle Screw DIAMETER 4.5mm AnyPlus® Poly-Axial Pedicle Screw DIAMETER 4.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
0911-4525 25 0921-4525 25
0911-4530 30 0921-4530 30
0911-4535 35 0921-4535 35
0911-4540 40 0921-4540 40
0911-4545 45 0921-4545 45
0911-4550 50 0921-4550 50
0911-4555 55 0921-4555 55
0911-4560 60 0921-4560 60
0911-4565 65 0921-4565 65
0911-4570 70 0921-4570 70

AnyPlus® Mono-Axial Pedicle Screw DIAMETER 5.5mm AnyPlus® Poly-Axial Pedicle Screw DIAMETER 5.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
0911-5525 25 0921-5525 25
0911-5530 30 0921-5530 30
0911-5535 35 0921-5535 35
0911-5540 40 0921-5540 40
0911-5545 45 0921-5545 45
0911-5550 50 0921-5550 50
0911-5555 55 0921-5555 55
0911-5560 60 0921-5560 60
0911-5565 65 0921-5565 65
0911-5570 70 0921-5570 70

AnyPlus® Mono-Axial Pedicle Screw DIAMETER 6.5mm AnyPlus® Poly-Axial Pedicle Screw DIAMETER 6.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
0911-6525 25 0921-6525 25
0911-6530 30 0921-6530 30
0911-6535 35 0921-6535 35
0911-6540 40 0921-6540 40
0911-6545 45 0921-6545 45
0911-6550 50 0921-6550 50
0911-6555 55 0921-6555 55
0911-6560 60 0921-6560 60
0911-6565 65 0921-6565 65
0911-6570 70 0921-6570 70
0921-6580 80
AnyPlus® Mono-Axial Pedicle Screw DIAMETER 7.5mm 0921-6590 90

Catalog Number Length (mm) AnyPlus® Poly-Axial Pedicle Screw DIAMETER 7.5mm
0911-7525 25
0911-7530 30 Catalog Number Length (mm)
0911-7535 35 0921-7525 25
0911-7540 40 0921-7530 30
0911-7545 45 0921-7535 35
0911-7550 50 0921-7540 40
0911-7555 55 0921-7545 45
0911-7560 60 0921-7550 50
0911-7565 65 0921-7555 55
0911-7570 70 0921-7560 60
0921-7565 65
AnyPlus® Mono-Axial Pedicle Screw DIAMETER 8.5mm 0921-7570 70
0921-7580 80
Catalog Number Length (mm) 0921-7590 90
0911-8525 25
0911-8530 30
0911-8535 35
0911-8540 40
0911-8545 45
0911-8550 50
0911-8555 55
0911-8560 60
0911-8565 65
0911-8570 70

20 GS Medical
Product Catalog

AnyPlus® 5.5 Implants

AnyPlus® Poly-Axial Pedicle Screw DIAMETER 8.5mm AnyPlus® Poly-Axial Reduction Screw DIAMETER 7.5mm
Catalog Number Length (mm) Catalog Number Length (mm)
0921-8525 25 0941-7525 25
0921-8530 30 0941-7530 30
0921-8535 35 0941-7535 35
0921-8540 40 0941-7540 40
0921-8545 45 0941-7545 45
0921-8550 50 0941-7550 50
0921-8555 55 0941-7555 55
0921-8560 60 0941-7560 60
0921-8565 65 0941-7565 65
0921-8570 70 0941-7565 65
0921-8580 80 0941-7570 70
0921-8590 90
AnyPlus® Poly-Axial Reduction Screw DIAMETER 8.5mm
AnyPlus® Poly-Axial Reduction Screw DIAMETER 4.5mm Catalog Number Length (mm)
Catalog Number Length (mm) 0941-8525 25
0941-4525 25 0941-8530 30
0941-4530 30 0941-8535 35
0941-4535 35 0941-8540 40
0941-4540 40 0941-8545 45
0941-4545 45 0941-8550 50
0941-4550 50 0941-8555 55
0941-4555 55 0941-8560 60
0941-4560 60 0941-8565 65
0941-4565 65 0941-8565 65
0941-4565 65 0941-8570 70
0941-4570 70

AnyPlus® Poly-Axial Reduction Screw DIAMETER 5.5mm AnyPlus® Open System Pedicle Screw Set Screw
Catalog Number Length (mm) Catalog Number
0941-5525 25 0954-0002
0941-5530 30
0941-5535 35
0941-5540 40
0941-5545 45
0941-5550 50
0941-5555 55
0941-5560 60
0941-5565 65
0941-5565 65
0941-5570 70

AnyPlus® Poly-Axial Reduction Screw DIAMETER 6.5mm

Catalog Number Length (mm)
0941-6525 25
0941-6530 30
0941-6535 35
0941-6540 40
0941-6545 45
0941-6550 50
0941-6555 55
0941-6560 60
0941-6565 65
0941-6565 65
0941-6570 70

GS Medical 21
Product Catalog

AnyPlus® 5.5 Implants

AnyPlus® Open System Lordosed Rods Adjustable Transverse Connectors
Catalog Number Length (mm) Catalog Number Length (mm)
GS0161-1035 35 1306-5530 30-36
GS0161-1040 40 1306-5535 35-46
GS0161-1050 50 1306-5540 40-56
GS0161-1060 60 1306-5550 50-76
GS0161-1070 70
GS0161-1080 80 AnyPlus® Lateral Connector – Open
GS0161-1090 90
GS0161-1100 100 Catalog Number Length (mm)
GS0161-1110 110 1326-5515 15
GS0161-1120 120 1326-5520 20
GS0161-1130 130 1326-5525 25
GS0161-1140 140 1326-5530 30
GS0161-1150 150 1326-5535 35
GS0161-1160 160 1326-5540 40
GS0161-1170 170
GS0161-1180 180
GS0161-1190 190
GS0161-1200 200 AnyPlus® Axial Rod Connector
AnyPlus® Open System Straight Rods Catalog Number Length (mm)
1350-5555 55
Catalog Number Length (mm) 1350-5560 60
0963-0040 40
0963-0050 50
0963-0060 60
0963-0070 70
0963-0080 80 AnyPlus® Domino Connector – Closed
0963-0090 90 Catalog Number Length (mm)
0963-0100 100 1360-5555 55
0963-0110 110 1360-5560 60
0963-0120 120
0963-0130 130
0963-0140 140
0963-0150 150
0963-0160 160 AnyPlus® Domino Connector-Open
0963-0180 180
0963-0200 200 Catalog Number Length (mm)
0963-0250 250 1370-5555 55
0963-0300 300 1370-5560 60
0963-0350 350
0963-0400 400
0963-0500 500
0963-0600 600

22 GS Medical
Product Catalog

Instruments

GS110 - GS110 - GS110 - GS110 - GS110 - GS110 - GS110 - 1920 (6.0), GS110 - 2312 (6.0),
0548 0558 0568 0578 0588 0416 GS110 - 1926 (5.5) GS110 - 2316 (5.5)
Tap 4.5mm Tap 5.5mm Tap 6.5mm Tap 7.5mm Tap 8.5mm Ball Tip Tester Kerrison Persuader Set Screw Starter

GS110 - 1536, GS110-3016(5.5), TL136106 (5.5)

GS110 - 0928 GS110-1536 (6.0), GS110-1546 (6.0), GS110-0923 (6.0) TL131106( 6.0)
Poly Screw GS110-1537 (5.5) GS110-1547 (5.5) GS110 - 1716 Poly Screw Torque Limiting Final Driver
Driver Shaft In-Situ Bender (LFT) In-Situ Bender (RGT) Rod Pusher Head Adjuster (11N +_ 10%)

GS110-2917 (5.5)
US14-3010 GS110-2916 (6.0) GS110-1219 (5.5) GS110-1311
Straight Ratchet US110-1002 Torque Wrench Handle GS110-1218 (6.0) (5.5 and 6.0)
Handle T Style Ratchet Handle for Transverse Link (5N +
_ 10%) Rod Gripper Power Rod Gripper

GS Medical 23
 Product Catalog

Instruments

GS110-1926 (5.5), GS1110-1217 (5.5), GS110-2917 (5.5),

GS110-1920 (6.0) GS110-1216 (6.0) GS110 - 2816 GS110 - 2716 GS110-2916 (6.0)
Kerrison Persuader Ring Handle Rod Holder Distractor Compressor Anti Torque Wrench

GS110 - 1526 GS110 - 0316 GS110 - 0326 GS110 - 0317 GS110 - 0327 GS110-2210 (5.5) GS110-0216
French Rod Straight Bone Probe Curved Bone Probe Straight Thoracic Curved Thoracic Rod Rocker Bone Awl
Bender (Steffee Tip) (Steffee Tip) Bone Probe Bone Probe

TL136106 (5.5) GS110-3516 C1202-019

US112-0610 (6.0) (5.5 and 6.0) GS110 - 3516 (5.5 and 6.0) GS110-1416 GS110-2316 (5.5),
Wrench for Driver for Set Screw Driver for Final Driver Shaft for US110 - 3701 (5.5) (5.5 and 6.0) GS110-2312 (6.0)
Transverse Link (V.1) Transverse Link (V.1) Transverse Link (V.3) Transverse Link (V.3) Rod Reduction Sheath Long Tab Breaker Set Screw Starter

24 GS Medical
Instrument Cleaning,
Care and Handling Policies
Overview Automated Cleaning and Disinfecting
Surgical instruments are supplied NON-STERILE, and must be sterilized An automatic cleaning process may be used i.e. ultrasonic cleaner
before use. After each use, instruments must be properly cleaned, or other related type machine that cleans and decontaminates items
disinfected, sterilized and stored. The following information outlines the provided their own unique instructions are followed. Be aware that loading
proper steps for reprocessing GS Medical surgical instruments. patterns, instrument cassettes, and other external factors may change the
effectiveness of the cleaning equipment.
Cleaning Accessories
Water - Cold deionized or reverse osmosis water should be used, as Inspection, Maintenance
temperatures above 140°F (60°C) will coagulate proteins, rendering and Testing
them difficult to remove from contaminated items. Surgical instrument and instrument cases are susceptible to damage from
prolong use, and through misuse or rough handling. Care must be taken
Detergent - Prepare detergent (i.e., LIQUI-NOX®, Alconox, Inc. 9.5 to avoid compromising their exact performance. To minimize damage, the
pH) per manufacturer recommendations ,or typical hospital grade following should be done. Inspect the instrument and cases for damage
instrument detergent or soap. when received and after each use and cleaning. Incompletely cleaned
instruments should be recleaned, and those that need repair set aside and
Manual Cleaning Accessories - Brushes, Gloves, Absorbent returned to GS Medical or its distributor. Instruments and instrument cases
Disposable Cloth must only be used for their intended purpose.
(i.e., KIMWIPE®, Kimtech Science)
Packaging
Limitations and Restrictions of Reprocessing The GS Medical instrument case is intended to protect instrumentation
Surgical instruments are designed for their durability and ability to reuse. during shipment. Any damage noted should be reported to GS Medical
GS Medical reusable instruments are typically manufactured from steel immediately. Damaged packaging may indicate the presence of unsafe
stainless steel, which permits a long life when handled and maintained product. If the product is damaged, the product should not be used and
properly. Repeated processing has minimal effect on these instruments. End should be returned.
of life is normally determined by wear and damage to use.
Sterilization
Cleaning / Disinfecting GS Medical surgical instruments manufactured of stainless steel or titanium
Warnings - When handling sharp instruments use extreme caution to may be steam sterilized with no detrimental effects. Steam Sterilization
avoid injury; consult with an infection control practitioner to develop Cycle instruments are supplied NON-STERILE and must be sterilized before
and verify safety procedures for all levels of direct instrument contact. use. The recommended sterilization process is high temperature steam
autoclave sterilization. It is also recommended that the trays be double
Clean Instruments as soon as possible after use. Do not allow blood wrapped using two standard sterilization wraps.
or debris to dry on the instruments. If cleaning must be delayed,
place groups on instruments in a covered container with water or an Validated Cycle is:
appropriate detergent to delay drying. Clean all instruments whether Method: Steam Cycle Pre-vacuum Temperature 270°F (132°)
or not they were used or inadvertently contacted blood or saline Exposure time: 4 minutes
solution. Drying Time: 20 minutes

Preparation for Cleaning - The cleaning process must be conducted Storage

so that all parts of the surgical instrument are exposed as permitted Surgical instruments that will not be utilized within a short period of time
by design. The cleaning process should include an individual properly and will not be immediately returned to GS Medical must be stored
gowned with appropriate glove and personal protective equipment. clean, decontaminated, and completely dry. The packaging that items
Items with lumens, cannulations, etc. must be carefully cleaned to are sterilized in may offer an effective barrier to prevent contamination.
remove all visible debris from the item. Instruments should be stored in a clean area until ready for use.

Manual Cleaning and Disinfection Sterilization

Clean instruments to remove gross contamination and disinfect All instruments must be sterilized according to the instructions outlined in
instruments to reduce the number of viable microorganisms. Rinse in warm the packaged insert-Instructions For Use (IFU) unless otherwise provided
water to remove any gross contamination. Wash with a detergent with a sterile.
pH of 7.0 to 10.0. Scrub the components with a soft brush. Rinse thoroughly
with warm running water. Dry the instrument with a clean , disposable,
absorbent cloth. Visually inspect for cleanliness. All visible surfaces, internal
and external, should be visibly inspected. If necessary re-clean / disinfect
the instrument until it is visibly clean.

Method Cycle Temperature Exposure Time

Steam Pre-Vacuum 270oF (132oC) 4 Minutes
Steam Gravity 250oF (121oC) 20 Minutes
Steam Gravity 273oF (134oC) 20 Minutes

GS Medical 25
Important Information on
the AnyPlus® & GSS™ Spinal
Systems
PURPOSE
The GSS™ and AnyPlus® Spinal Systems are intended to help provide Possible Adverse Events
immobilization and stabilization segments as an adjunct to fusion of the All of the possible adverse events associated with spinal fusion surgery
thoracic, lumbar, and /or sacral spine. without instrumentation are possible. With instrumentation, a listing of
potential adverse events includes, but is not limited to:
DESCRIPTION 1. Early or late loosening of any or all of the components.
The GSS™ and AnyPlus® Spinal Systems consist of a variety and sizes of 2. Disassembly, bending, and/or breakage of any or all of the
rods, screws, transverse links, as well as implant components which can be components.
rigidly locked into a variety of configurations with each construct being 3. Foreign body (allergic) reaction to implants, debris, corrosion products
tailor-made for the individual case. (for, crevice, fretting, and/or general corrosion), including metallosis
staining, tumor formation, and/or autoimmune disease.
The GSS™ and AnyPlus® Spinal System implants are made out of medical 4. Pressure on the skin from the component parts in patients with
grade titanium alloy described by such standards as ASTM F67 or ASTM inadequate tissue coverage over the implant possibly causing skin
F136 or ISO 5832-3 or 5832-2. GS Medical warranties and merchantability penetration, irritation, fibrosis, necrosism, and/or pain. Bursitis. Tissue
and fitness for a particular purpose or use are specifically excluded. See or neve damage caused by improper positioning and placement of
the GSS™ Catalog for further information about warranties and limitations implants or instrument.
of liability. 5. Post-operative change in spinal curvature, loss of correction, height,
and/or reduction.
Never use stainless steel and titanium implants in the same construct. 6. Infection.
To achieve the best result, do not use any of the GSS™ and AnyPlus® 7. Dural tears, pseudomeningocele, fistula, persistent cerebrospinal fluid
Spinal System components with components from any other system or leakage, meningitis.
manufacturer unless specifically allowed to do so in this or another GS 8. Loss of neurological function (e.g, sensory and/or motor), including
Medical document. As with all orthopaedic and neurosurgical implants, paralysis (complete or incomplete), dysesthesias, hyperesthesia,
none of the GSS™ and AnyPlus® Spinal System components should ever be anesthesia, paresthesia, appearance of radiculopathy, and/or the
reused under any circumstance. development or continuation of pain, numbness, neuroma, spasms,
sensory loss, tingling sensation, and/or visual deficits.
INDICATIONS, CONTRAINDICATIONS AND POSSIBLE ADVERSE EVENTS. 9. Cauda equina syndrome, neuropathy, neurological deficits (transient
The GSS™ and AnyPlus® Spinal Systems are non-cervical spinal fixation or permanent), paraplegia, paraparesis, reflex deficits, irritation,
device intended for use as a posterior pedicle screw fixation system, a arachnoiditis, and/or muscle loss.
posterior non-pedicle screw fixation system, or as an anterolateral fixation 10. Urinary retention or loss of bladder control or other types of urological
system. Pedicle screw fixation is limited to skeletally mature patients. The system compromise.
devices are indicated for all of the following indications regardless of the 11. Scar formation possibly causing neurological compromise or
intended use. cpmpression around nerves and/or pain.
12. Fracture, microfracture, resorption, damage, or penetration of any
1. Degenerative Disc Disease (defined as discogenic back pain with spinal bone (including the sacrum, pedicles, and/or vertebral body)
degeneration of the disc confirmed by history and radiographic and/or bone graft or bone graft harvest site at, above, and/or below
studies. ) the level of surgery. Retropulsed graft.
13. Herniated nucleus pulposus, disc disruption or degeneration at,
DESCRIPTION above, or below the level of surgery
Contraindications include, but are not limited to: 14. Non-union (or pseudarthrosis). Delayed union. Mal-union.
15. Cessation of any potential growth of the operated portion of spine.
1. Active infectious process or significant risk of infection 16. Loss of or decrease in spinal mobility or function.
(immunocomprise). 17. Inability to perform the activities of daily living.
2. Signs of local inflammation. 18. Bone loss or decrease in bone density, possibly caused by stress
3. Fever or leukocytosis. shielding.
4. Mordid obesity 19. Graft donor site complications including pain, fracture, or wound
5. Pregnacy healing problems.
6. Mental illness 20. Ileus, gastritis, bowel obstruction or loss of bowel control or other types
7. Grossly distorted anatomy caused by congenital abnormalities. of gastrointestinal compromise.
8. Any other medical or surgical condition which would preclude the 21. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension,
potential benefit of spinal implant surgery, such as the presence embolism, stoke, excessive bleeding, phlebitis, wound necrosis,
of congenital abnormalities, elevation of sedimentation rate wound dehiscence, damage to blood vessels, or other types of
unexplained by other diseases, elevation of white blood count(WBC), cardiovascular system compromise.
or a marked left shift in the WBC differential count. 22. Reproductive system compromise, including sterility, loss of consortium
9. Rapid joint diseases, bone absorption, osteopenia, osteomalacia and sexual dysfunction.
and/or osteoporosis. 23. Development of respiratory problems e.g. pulmonary embolism,
10. Suspected or documented metal allergy or intolerance. atelectasis, bronchitis, pneumonia, etc.
11. Any case not needing a bone graft and fusion. 24. Change in mental status.
12. Any case where the implant components selected for use would be 25. Death
too large or too small to achieve a successful result.
13. Any case requires the mixing of metals from two different components Note: Additional surgery may be necessary to correct some of these
or system. potential adverse events.
14. Any patient giving inadequate tissue coverage over the operative site
or inadequate bone stock or quality. Warning and Precautions
15. Any patient which implant utilization would interfere with anatomical Federal law restricts this device to sale by or on the order of a licensed
structures or expected physiological performance. physician.
16. Any patient unwilling to follow postoperative instruction.
17. Any case not describe in the indications.

continued

26 GS Medical
Important Information on
the AnyPlus® & GSS™ Spinal
Systems Intraoperative
The safety and effectiveness of spinal systems have been established only 1. Only patients that meet the criteria described in the indications
for spinal conditions with significant mechanical instability or deformity should be selected.
requiring fusion with instrumentation. These conditions are significant 2. Extreme caution should be used around the spinal cord and
mechanical instability or deformity of the thoracic and cervical spine nerve roots. Damage to the nerves may cause loss of neurological
secondary to degenerative spondylolisthesis with objective evidence of functions.
neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal 3. Breakage, slippage, or misuse of instruments or implant components
tumor and failed previous fusion (pseudoarthrosis). may cause injury to the patient or operative personnel.
4. The rods should not be repeatedly or excessively bent. The rods
Only experienced spinal and neurospinal surgeons should perform the should not be reverse bent in the same location. Use great care to
implantation of spinal systems with specific training in the use of this spinal insure that the implant surfaces are not scratched or notched, since
system because this is a technically demanding procedure presenting a such actions may reduce the functional strength of the construct.
risk of serious injury to the patient. If the rods are cut to length, they should be cut in such a way as to
create a flat, non-sharp surface perpendicular to the midline of the
Based on the fatigue testing results, the surgeon should consider the rod. Cut the rods outside the operative field. Whenever possible, use
levels of implantation, patient weight, patient activity level, other patient pre-cut rods of the length needed.
conditions, etc. which may impact the performance of the system. 5. Whenever possible or necessary, an imaging system should be
utilized to facilitate surgery.
Warning and Precautions 6. To insert a screw properly, a guidewire should first be used, followed
Although the physician is the designated intermediary between the by a sharp tap. Caution: Be careful that the guidewire, if used, is
company and the patient, the important medical information given in this not inserted too deep, becomes bent, and/or breaks. Ensure that
document should be conveyed to the patient. the guidewire does not advance during tapping or screw insertion.
Remove the guidewire and make sure screw is intact. Failure to do so
CAUTION: National law restricts these devices for sale by or on the order of may cause the guidewire or part of it to advance through the bone
a physician. and into a location that may cause damage to underlying structures.
Do not overtap or use a screw that is either too long or too large.
CAUTION: FOR USE OR BY THE ORDER OF A PHYSICIAN ONLY. Over tapping or using an incorrectly sized screw may cause nerve
damage, hemorrhage, or the other possible adverse events listed
Implant Selection elsewhere in this package insert.
The selection of the proper size, shape and design of the implant for each 7. Bone graft may be placed in the area to be fused and graft material
patient is crucial to the success of the procedure. Metallic surgical implants must extend from the upper to the lower vertebrae being fused.
are subject to repeated stresses in use, and their strength is limited by the 8. To assure maximum stability, two additional transverse connectors
need to adapt the design to the size and shape of human bones. Unless may be implanted on the two lower adjacent vertebrae being fused.
great care is taken in patient selection, proper placement of the implant, 9. Bone cement should not be used because the safety and the
and postoperative management to minimize stresses on the implant, such effectiveness of bone cement has not been determined for spinal
stresses may cause metal fatigue and consequent breakage, bending or uses, and this material will make removal of the components difficult
loosening of the device before the healing process is complete, which may or impossible. The heat generated from the curing process may also
result in further injury or the need to remove the device prematurely. cause neurological damage and bone necrosis.
10. Before closing the soft tissues, provisionally tighten (finger tighten)
Device Fixation all of the set screws or screws, especially screws or set screws that
For self breaking plugs, always hold the assembly with the Counter have a break-off feature. Once this is completed go back and firmly
Torque device. Tighten and break-off the head of the set screw to leave tighten all of the screws and set screws. Recheck the tightness of all
the assembly at optimum fixation security. After the upper part of the nuts or screws after finishing to make sure that none loosened during
self breaking set screw has been sheared off, further re-tightening is not the tightening of the other set screws or screws. Failure to do so may
necessary and not recommended. cause loosening of the other components.

The head part should not remain in the patient. After the upper part of the Postoperative
self breaking set screw has been sheared off, re-adjustment is not possible It is important that immobilization of the spinal surgical site be maintained
unless the set screw id removed and replaced with a new one. until firm bony union is established and confirmed by roentgenographic
examination. If a state of non-union persists or if the components loosen,
Preoperative bend, and/or break, the device(s) should be revised and/or removed
1. Only patients that meet the criteria described in the indications immediately before serious injury occurs. The patient must be adequately
should be selected. warned of these hazards closely supervised to insure cooperation until
2. Patient conditions and/or predispositions such as those addressed in bony union is confirmed.
the aforementioned contraindications should be avoided.
3. Care should be used in the handling and storage of the implant As a precaution, before patients with implants receive any subsequent
component. The implant should not be scratched or otherwise surgery (such as dental procedures), prophylactic antibiotics may be
damaged. Implant and instruments should be protected during considered, especially for high-risk patients.
storage, especially from corrosive environments.
4. An adequate inventory of implants should be available at the time of The GSS™ and AnyPlus® Spinal System implants are temporary internal
surgery, normally a quantity in excess of what is expected to be used. fixation devices. Internal fixation devices are designed to stabilize the
5. Since mechanical arts are involved, the surgeon should be familiar operative site during the normal healing process. After the spine is fused,
with the various components before using the equipment and should these devices serve no functional purpose and may be removed. While the
personally assemble the devices to verify that all parts and necessary final decision on implant removal is up to the surgeon and patient, in most
instruments are present before the surgery begins. The GSS™ Spinal patients, removal is indicated because the implants are not intended to
system components (described in the DESCRIPTION section) are not transfer or support forces developed during normal activities. If the device
to be combined with the components from another manufacturer. is not removed following completion of its intended use, one or more of
Different metal types should never be used together. the following complications may occur: (1) Corrosion, with localized tissue
6. All components and instruments should be cleaned and sterilized reaction or pain; (2) Migration of implant position, possibly resulting in
before use. Additional sterile components should be available in case injury; (3) Risk of additional injury from postoperative trauma; (4) Bending,
of an unexpected need. loosening and breakage, which could make removal impractical or

continued

GS Medical 27
Important Information on
the AnyPlus® & GSS™ Spinal
Systems
difficult; (5) Pain, discomfort, or abnormal sensations due to the presence Product Complaints
of the device; (6) Possible increased risk of infection; (7) Bone loss due Any health professional having a complaint or grounds for dissatisfaction
to stress shielding; and (8) Potential unknown and/or unexpected long relating to the quality of the product, its identity, its durability, its reliability,
term effects such as carcinogenesis. Implant removal should be followed safety, effectiveness and/or performance should notify GS Medical.
by adequate postoperative management to avoid fracture, re-fracture, or Moreover, if a device malfunctioned, GS Medical or its distributor must be
other complications. advised immediately.

Any retrieved devices should be treated in such a manner that reuse in If a GS Product has ever worked improperly and could have caused or
another surgical procedure is not possible. As with all orthopedic implants, contributed to the serious injury or death of a patient, the distributor must
the be informed as soon as possible by telephone, fax or in writing. For all
complaints, please include the device name and reference along with
GSS™ and AnyPlus® Spinal System components should never be reused the lot number of the component(s), your name and address and an
under any circumstances. exhaustive description of the event to help GS Medical understand the
causes of the complaint.
Packaging
The implants are delivered in packages; these must be intact at the time of For additional information on the products listed in this guide, please
receipt. contact the GS Medical Customer Service Department:

The systems are sometimes supplied as a complete set: implants and GS Medical Co., Ltd.
instruments are arranged on trays and placed in specially designed Seoul Office: 12F Kolon Digital Tower Aston, 505-14, Gasan-Dong,
storage boxes. Geumchon-Gu, Seoul, Korea 153-803

CLEANING AND DECONTAMINATION Tel: +82-2-2082-7777 Fax: 82-2-2082-7778

Unless just removed from an unopened GS Medical package, all
instruments and implants must be disassembled and cleaned using Factory: #90, Osongsaengmyeong 4-Ro, Osong-Eup, Cheongwon-Gun,
neutral cleaners before sterilization and introduction into a sterile surgical Chungbuk, 363-951, Korea
field or (if applicable) return of the product to GS Medical. Cleaning and
disinfecting of instruments can be performed with aldehyde-free solvents at Tel: +82-43-237-7393 Fax : +82-43-237-7403
higher temperatures. Cleaning and decontamination must include the use www.gsmedi.com
of neutral cleaners followed by a deionized water rinse.
GS Medical USA
Note: Certain cleaning solutions such as those containing formalin, 6 Wrigley
glutaraldehyde, bleach and/or other alkaline cleaners may damage some Irvine, CA 92618
devices, particularly instruments; these solutions should not be used. Also,
many instruments require disassembly before cleaning. Toll free: +1-866-904-8144
Fax: +1-866-600-9712
All products should be treated with care. Improper use or handling may www.gsmedicalusa.com
lead to damage and/or possible improper functioning of the device.

STERILIZaTION
Unless marked sterile and clearly labeled as such in an unopened sterile
package provided by the company, all implants and instruments used
in surgery must be sterilized by the hospital or surgery center prior to use.
Remove all packaging materials prior to sterilization. Only sterile products
should be placed in the operative field. For a 10-6 Sterility Assurance Level,
these products are recommended to be steam sterilized by the hospital
using one of the three sets of process parameters below:

NOTE: Because of the many variables involved in sterilization, each

medical facility should calibrate and verify the sterilization process (e.g.
temperature, times) used for their equipment. For outside the United States,
some non-US. Health Care Authorities recommend sterilization according
to these parameters so as to minimize the potential risk of transmission of
Creutzfeldt-Jacob disease, especially of surgical instruments that could
come onto contact with the central nervous system. Remove all packaging
materials prior to sterilization. Use only sterile products in the operative field.

28 GS Medical
GSS™is a Trademark of GS Medical Company, Ltd.

AnyPlus® is a Registered Trademark of GS Medical Company, Ltd. ©Copyright 2015, GS

Medical Company, Ltd.

Caution: Federal Law (USA) restricts these devices for sale by or on the order of a
physician.

The surgical technique described hereafter in this surgical technique guide is

considered standard use by the manufacturer, GS Medical, Ltd. The guide is put forth as
a recommendation and should be used in tandem with the surgical knowledge of the
surgeon.

For additional information on the products listed in this guide, please contact the GS
Medical Customer Service Department:

GS Medical USA
Attn: Customer Service
6 Wrigley
Irvine, CA 92618
Office: 866-904-8144
www.gsmedicalusa.com