1

Table of contents :
Introduction
Universal Pedicular Screw System Product feature Indications & Contraindications 2 3-4 5

Surgical Technique

Surgical Technique Step 1 : Creating a screws hole Step 2 : Radiographic control Step 3 : Tapping Step 4 : Screws insertion Step 5 : Bending and attaching the rods Step 6 : Rod placement Step 7 : Insert the set screws Step 8 : Insert the set screws(2) Step 9 : Distraction / Compression Step 10 : Tightening of the set screws

6 - 13 6 7 7 8 8 9 10 11 12 13

Ordering information

Implants Mono-Axial Screws (Reduction) Mono-Axial Screws (non-Reduction) Poly-Axial Screws (Reduction) Poly-Axial Screws (non-Reduction) Set screw & Crosslinks Dynamic Poly-Axial Screws (Reduction) Dynamic Poly-Axial Screws (non-Reduction) Rods Hooks Instruments Containers & Trays

14-48 14-15 16-17 18-19 20-21 22 23-24 25-26 27-28 29-32 33-44 45-48

Introduction :
Universal Pedicular Screw System

Screw,hooks,rods and clamps

apThe Spinal System is a set of instruments and implants for the surgical ap proaches of deformity, degenerative and trauma indications.

Key Features & Benefits :

Highly versatile
- Pre-bent rods - Optimal selection of implants - Easy-to-use instrumentation Best performance - Cap thread designed to reduce cross threading - Visual and tactile indicators to ensure proper implant and instrument assembly - Buttress Thread enhances optimal bone purchase Easy to use - Standard Instruments - Snap-on,telescoping transverse connectors provides easy attachment

Please refer to the package insert for a complete list of indications, contraindications, precautions and warnings.

Product features
Pedicular Screw :
The Spinal Fixation System is an internal fixation device for spinal surgery comprising of pedicle screws, connectors, rods, housings and transverse link assemblies. Various forms and sizes of implants are available so that adaptations can be made to take into account the pathology and individual patient.

Locking Nut Single size Stable thread profile Unique rotating saddle design or single piece

Screw Head Unique thread design Low profile Color code by size Reduction & Non-Reduction Polyaxial and Monoaxial

Screw Shaft Self-tapping design Diameters are from 4.5mm to 8.5mm Increased pull-out strength Easy rod capture (50 rom)

Non-Reduction Screw Set Screw

Screw heads are color coded by screw diameter

4.5mm 5.5mm 6.5mm 7.5mm

Reduction Screw

Single Piece Set Screw (Optional)

Product features Cross-Link :

Angulation

Tra

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Rotaion

Indications / Contraindications :
When used as a fixation system of the non-cervical posterior spine in skeletally mature patients, the Spine System is indicated for one or more of the following:

Indications
1 2 3 4 5 6 7 8 9 10 11 12 Degenerative spondylolisthesis Fracture DDD (confirmed by patient history and radiographic studies) Spinal tumors Dislocation Scoliosis Kyphosis Failed previous fusion Having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint Who are receiving fusions using autogenous bone graft only Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below) Who are having the device removed after the development of a solid fusion mass

Contraindications (Contraindications include, but are not limited to) :

1 2 3 4 5 6 7 8 9 Active infectious process or significant risk of infection (immunocompromise) Signs of local inflammation Fever or leukocytosis Morbid obesity Pregnancy Mental illness Grossly distorted anatomy caused by congenital abnormalities. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis or osteopenia is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. Suspected or documented metal allergy or intolerance. Any case not needing a bone graft and fusion. Any case where the implant components selected for use would be too large or too small to achieve a successful result. Any case that requires the mixing of metals from two different components or systems. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. Any patient unwilling to follow postoperative instructions.

10 11 12 13 14 15 16

Surgical Technique :
Step 1 : Creating a screw hole
Instrument : SCC110-0211 SCC110-0311 SCC110-0410 AWL Probe(Straight) Tester

Determine the screw insertion point, and use the starter Awl to drill a hole into the cortical bone in the decided position.
AWL SCC 110-0211

Insert the pedicle probe into the hole , and gently push it into the pedicle.

PROBE (STRAIGHT) SCC110-0311

Confirm by using the Tester whether the created screw hole has deviated out of the bone or not.

TESTER SCC110-0410

Surgical Technique :
Step 2 : Radiograhic control
Instrument : SCC110-0110 SCC110-0120 Guide Pin 100mm Guide Pin 100mm w.Stop

When implementing radiographic control measures, use the pedicle marker.

GUIDE PIN 100 SCC110-0110

GUIDE PIN 100+STOP SCC110-0120

Step 3 : Tapping
Instrument : SCC110-0540/C SCC110-0550/C SCC110-0560/C SCC110-0570/C SCC110-0580/C SCC110-0410 Tap 4.5mm Tap 5.5mm Tap 6.5mm Tap 7.5mm Tap 8.5mm Tester
TAP SCC110-0XXX

TESTER SCC110-0410

Carry out tapping using the tap, the size of which should match that of the screw. The screw is not a self-tapping type. After reconfirming by using the Tester.

Surgical Technique :
Step 4 : Screw insertion
Instrument : SCC110-0951 SCC110-0955 SCC110-2425 M SCC110-0951C SCC110-0955C
Polyaxial Screw Driver Shaft Monoaxial Screw driver Shaft Screw driver (Medium) Polyaxial Screw Driver Shaft , Cannulated Monoaxial Screw driver Shaft , Cannulated

Attach the screwdriver to the screw. The screwdriver is equipped with a merchanism to safely grasp the screw. After the screw is inserted, the driver comes off from the screw when turning the Nut counter clockwise.

POLYAXIAL SCREWDRIVER SHAFT SCC110-0951/C

MONOAXIAL SCREWDRIVER SHAFT SCC110-0955/C

SCREWDRIVER (MEDIUM) SCC110-2425M

Step 5 : Bending and attaching the rod

Instrument :
SCC110-1520 French Bender

Fig. I

Fig. II

Fig. III

It is not possible to obtain a sufficient tightening strength at the connection unless the rod securely touches the screw head bottom. For a safe connection, bend the rod appropriately. ( see fig I , II , III ) This operation is particularly Important when using the monoaxial screw.

FRENCH BENDER SCC110-1520

Surgical Technique :
Step 6 : Rod insertion
Instrument : SCC110-1211
Rod Holder

Attatch the rod to the screw head by use of a Rod Holder.

ROD HOLDER SCC110-1211

Surgical Technique :
Step 7 : Insert the Set Screw
When the rod is not securely touching the screw head base,(Fig.2) sufficient tightening strengh cannot be obtained at the connection. For a safe conection, it is necessary to push the rod into the screw bottom. To attach the screw and the rod closely,the rod pusher or the rod fork.

Fig. I

Fig. II

This operation to push the rod into the screw bottom is especially important when using the monoaxial screw.

Self holding

ROD PUSHER SCC110-1711

ROD FORK SCC110-1810

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Surgical Technique :
Step 8 : Insert the Set Screw(2)
Instrument : SCC 110-1711 SCC 110-1810 SCC 110-1920 Rod Pusher Rod Fork Persuader

Fig. I

Fig. II

Before putting the plug into the screw, confirm that the rod is securely touching the screw head bottom as shown in the left figure marked with "O" . In the case marked with "X", make sure that the rod securely touches the screw head bottom in place, by bending or pushing the rod place, by using the rod approximator.

ROD PUSHER SCC110-1711

ROD FORK (Adjustable) SCC110-1810

PERSUADER SCC110-1920

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Surgical Technique :
Step 9 : Compression / Distraction
Instrument : SCC110-2711 SCC110-1311 SCC110-2811
Compressor Rod Clamp Distractor

Use the distraction forceps to distract the construct into the desired position. Then provisionally tighten the set screw. Once distraction is achieved in all levels final tighten all set screws.

Use the compression forceps to compress the construct into the desired position. then procisionally tighten the set screw. Once distraction is achieved in all levels final tighten all set screws.

Final tightening illustrated in step 10

Distractor SCC110-2811

Rod camp SCC110-1311

Compressor SCC110-2711

12

Surgical Technique :
Step 10 : Tightening of the Set Screw
Instrument : SCC110-2441 SCC110-2420 S SCC110-2425 M SCC110-2430 L SCC110-2911
T-handle(Torque-limiter) Screw driver (small) Screw driver (medium) Screw driver (Large) Anti-torque wrench

For the final tightening of the Set Screw, use the torque driver, the driver shaft, and the anti rotator handle. Procedure for using a torque-limiting driver is shown here as example. Attach the anti rotator to the screw head and insert the driver shaft to tighten the Set Screw. The driver clicks and runs idle when it reaches the prescribed torque of 12 NM.
T-hadle(Torque-limiter) SCC110-2441

Screw driver (medium) SCC110-2420 S SCC110-2425 M SCC110-2430 L

Anti-torque wrench SCC-110-2911

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Ordering Information : Mono-Axial Reduction Screws :

Implants :
Mono-Axial Screw 4.5mm Reduction
MSR 08-4520 MSR 08-4525 MSR 08-4530 MSR 08-4535 MSR 08-4540 MSR 08-4545 MSR 08-4550 MSR 08-4555 MSR 08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Mono-Axial Screw 5.5mm Reduction

MSR 09-5520 MSR 09-5525 MSR 09-5530 MSR 09-5535 MSR 09-5540 MSR 09-5545 MSR 09-5550 MSR 09-5555 MSR 09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

14

Ordering Information : Mono-Axial Reduction Screws :

Implants :
Mono-Axial Screw 6.5mm Reduction
MSR 10-6520 MSR 10-6525 MSR 10-6530 MSR 10-6535 MSR 10-6540 MSR 10-6545 MSR 10-6550 MSR 10-6555 MSR 10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Mono-Axial Screw 7.5mm Reduction

MSR 11-7520 MSR 11-7525 MSR 11-7530 MSR 11-7535 MSR 11-7540 MSR 11-7545 MSR 11-7550 MSR 11-7555 MSR 11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

15

Ordering Information : Mono-Axial Non-Reduction Screws :

Implants :
Mono-Axial Screw 4.5mm Non-Reduction
MSS 08-4520 MSS 08-4525 MSS 08-4530 MSS 08-4535 MSS 08-4540 MSS 08-4545 MSS 08-4550 MSS 08-4555 MSS 08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Mono-Axial Screw 5.5mm Non-Reduction

MSS 09-5520 MSS 09-5525 MSS 09-5530 MSS 09-5535 MSS 09-5540 MSS 09-5545 MSS 09-5550 MSS 09-5555 MSS 09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

16

Ordering Information : Mono-Axial Non-Reduction Screws :

Implants :
Mono-Axial Screw 6.5mm Non-Reduction
MSS 10-6520 MSS 10-6525 MSS 10-6530 MSS 10-6535 MSS 10-6540 MSS 10-6545 MSS 10-6550 MSS 10-6555 MSS 10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Mono-Axial Screw 7.5mm Non-Reduction

MSS 11-7520 MSS 11-7525 MSS 11-7530 MSS 11-7535 MSS 11-7540 MSS 11-7545 MSS 11-7550 MSS 11-7555 MSS 11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

17

Ordering Information : Poly-Axial Reduction Screws :

Implants :
Poly-Axial Screw 4.5mm Reduction
PSR 08-4520 PSR 08-4525 PSR 08-4530 PSR 08-4535 PSR 08-4540 PSR 08-4545 PSR 08-4550 PSR 08-4555 PSR 08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Poly-Axial Screw 5.5mm Reduction

PSR 09-5520 PSR 09-5525 PSR 09-5530 PSR 09-5535 PSR 09-5540 PSR 09-5545 PSR 09-5550 PSR 09-5555 PSR 09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

18

Ordering Information : Poly-Axial Reduction Screws :

Implants :
Poly-Axial Screw 6.5mm Reduction
PSR 10-6520 PSR 10-6525 PSR 10-6530 PSR 10-6535 PSR 10-6540 PSR 10-6545 PSR 10-6550 PSR 10-6555 PSR 10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Poly-Axial Screw 7.5mm Reduction

PSR 11-7520 PSR 11-7525 PSR 11-7530 PSR 11-7535 PSR 11-7540 PSR 11-7545 PSR 11-7550 PSR 11-7555 PSR 11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

19

Ordering Information : Poly-Axial Non-Reduction Screws :

Implants :
Poly-Axial Screw 4.5mm Non-Reduction
PSS 08-4520 PSS 08-4525 PSS 08-4530 PSS 08-4535 PSS 08-4540 PSS 08-4545 PSS 08-4550 PSS 08-4555 PSS 08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Poly-Axial Screw 5.5mm Non-Reduction

PSS 09-5520 PSS 09-5525 PSS 09-5530 PSS 09-5535 PSS 09-5540 PSS 09-5545 PSS 09-5550 PSS 09-4555 PSS 09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

20

Ordering Information : Poly-Axial Non-Reduction Screws :

Poly-Axial Screw 6.5mm Non-Reduction
PSS 10-6520 PSS 10-6525 PSS 10-6530 PSS 10-6535 PSS 10-6540 PSS 10-6545 PSS 10-6550 PSS 10-6555 PSS 10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Poly-Axial Screw 7.5mm Non-Reduction

PSS 11-7520 PSS 11-7525 PSS 11-7530 PSS 11-7535 PSS 11-7540 PSS 11-7545 PSS 11-7550 PSS 11-7555 PSS 11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

21

Ordering Information : Set screw and Cross-Link :

Set screw
CHM01-10 With Saddle

CHM01-12

Without Saddle

Crosslink
Range SCC0120-0035 SCC0120-0042 SCC0120-0050 40-45 mm 45-55 mm 55-65 mm

22

Ordering Information : Dynamic Poly-Axial Reduction Screws: Non-fusion

Implants :
Dynamic Poly-Axial Screw 4.5mm Reduction
DPR08-4520 DPR08-4525 DPR08-4530 DPR08-4535 DPR08-4540 DPR08-4545 DPR08-4550 DPR08-4555 DPR08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Dynamic Poly-Axial Screw 5.5mm Reduction

DPR09-5520 DPR09-5525 DPR09-5530 DPR09-5535 DPR09-5540 DPR09-5545 DPR09-5550 DPR09-5555 DPR09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

23

Ordering Information : Dynamic Poly-Axial Reduction Screws: Non-fusion

Implants :
Dynamic Poly-Axial Screw 6.5mm Reduction
DPR10-6520 DPR10-6525 DPR10-6530 DPR10-6535 DPR10-6540 DPR10-6545 DPR10-6550 DPR10-6555 DPR10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Dynamic Poly-Axial Screw 7.5mm Reduction

DPR11-7520 DPR11-7525 DPR11-7530 DPR11-7535 DPR11-7540 DPR11-7545 DPR11-7550 DPR11-7555 DPR11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

24

Ordering Information : Dynamic Poly-Axial Non-Reduction Screws : Non-fusion

Implants :
Dynamic Poly-Axial Screw 4.5mm Non-Reduction
DPS08-4520 DPS08-4525 DPS08-4530 DPS08-4535 DPS08-4540 DPS08-4545 DPS08-4550 DPS08-4555 DPS08-4560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Dynamic Poly-Axial Screw 5.5mm Non-Reduction

DPS09-5520 DPS09-5525 DPS09-5530 DPS09-5535 DPS09-5540 DPS09-5545 DPS09-5550 DPS09-5555 DPS09-5560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

25

Ordering Information : Dynamic Poly-Axial Non-Reduction Screws : Non-fusion

Implants :
Dynamic Poly-Axial Screw 6.5mm Non-Reduction
DPS10-6520 DPS10-6525 DPS10-6530 DPS10-6535 DPS10-6540 DPS10-6545 DPS10-6550 DPS10-6555 DPS10-6560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

Dynamic Poly-Axial Screw 7.5mm Non-Reduction

DPS11-7520 DPS11-7525 DPS11-7530 DPS11-7535 DPS11-7540 DPS11-7545 DPS11-7550 DPS11-7555 DPS11-7560 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm

26

Ordering Information : Rod to rod connectors :

Implants :

Extention connector EC1-0001

Parallel connector PC-1-0001

27

Ordering Information : Rods :

Ti Rod (Straight)
SCC02-0040 SCC02-0050 SCC02-0060 SCC02-0070 SCC02-0080 SCC02-0090 SCC02-0100 SCC02-0110 SCC02-0120 SCC02-0130 SCC02-0140 SCC02-0150 SCC02-0160 SCC02-0170 SCC02-0180 SCC02-0190 SCC02-0200 SCC02-0250 SCC02-0300 SCC02-0350 SCC02-0400 SCC02-0500 SCC02-0600 40mm 50mm 60mm 70mm 80mm 90mm 100mm 110mm 120mm 130mm 140mm 150mm 160mm 170mm 180mm 190mm 200mm 250mm 300mm 350mm 400mm 500mm 600mm

Ti rod curved
SCC03-0080 SCC03-0120 SCC03-0160 80mm 120mm 160mm

28

Ordering Information : Hooks :

Pedicle hook
HS20-0804 HS20-0805 HS20-0806 HS20-0807 HS20-0808 HS20-0809 HS20-0810 20mm 21mm 22mm 23mm 24mm 25mm 26mm

Narrow laminar hook

HS21-0504 HS21-0505 HS21-0506 HS21-0507 HS21-0508 HS21-0509 HS21-0510 20mm 21mm 22mm 23mm 24mm 25mm 26mm

29

Ordering Information : Hooks :

Wide larminar hook
HS22-0704 HS22-0705 HS22-0706 HS22-0707 HS22-0708 HS22-0709 HS22-0710 20mm 21mm 22mm 23mm 24mm 25mm 26mm

Angled larminar hook

HS23-0505 HS23-0507 HS23-0509 HS23-0511 HS22-0505 HS22-0507 HS22-0509 HS22-0511 20mm 21mm 22mm 23mm 24mm 25mm 27mm 29mm

30

Ordering Information : Hooks :

Laminar hook (Left)
HS25-0505 HS25-0507 HS25-0509 HS25-0511 24mm 26mm 28mm 30mm

Laminar hook (Right)

HS26-0505 HS26-0507 HS26-0509 HS26-0511 24mm 26mm 28mm 30mm

Laminar hook w. Extended body

HS27-0504 HS27-0505 HS27-0506 HS27-0507 HS27-0508 HS27-0509 HS27-0510 23.5mm 24.5mm 25.5mm 26.5mm 27.5mm 28.5mm 29.5mm

31

Ordering Information : Instruments : Pins :

Implants :
SCC110-0110 GUIDE PIN 100mm

SCC110-0120

GUIDE PIN 100mm W.STOP

32

Ordering Information : Instruments :

SCC110-0211

AWL

SCC110-0321

PROBE (CURVED)

33

Ordering Information : Instruments :

SCC110-0311 PROBE (STRAIGHT)

SCC110-0410

TESTER

34

Ordering Information : Instruments :

SCC110-0630 T-HANDLE LARGE

SCC112-0610

T-HANDLE SMALL

SCC110-2441

TORQUE LIMITING T-HANDLE 12 nm

35

Ordering Information : Instruments :

SCC110-0640 I-HANDLE

SCC110-0641

EXTENDED I-HANDLE

36

Ordering Information : Instruments :

TAP : NON-CANNULATED
SCC110-0540 SCC110-0550 SCC110-0560 SCC110-0570 4.5mm 5.5mm 6.5mm 7.5mm

TAP : CANNULATED
SCC110-0540C SCC110-0550C SCC110-0560C SCC110-0570C 4.5mm 5.5mm 6.5mm 7.5mm

Rod Template
RT-1-0001 200 mm

37

Ordering Information : Instruments :

SCC110-0951 SCC110-0955 POLY-AXIAL SCREW DRIVER SHAFT MONO-AXIAL SCREW DRIVER SHAFT

SCC110-0951C SCC110-0955C

POLY-AXIAL SCREW DRIVER SHAFT , CANNULATED MONO-AXIAL SCREW DRIVER SHAFT , CANNULATED

SCC110-2420 S SCC110-2425 M SCC110-2430 L

SCREW DRIVER (SMALL) SCREW DRIVER (MEDIUM) SCREW DRIVER (LARGE)

SCC110-3311

TRANSVERSE WRENCH TIP

38

Ordering Information : Instruments :

SCC110-1211 ROD HOLDER

SCC110-1410

CUTTING FORCEP

39

Ordering Information : Instruments :

SCC110-1311 ROD CLAMP

SCC110-1520

FRENCH BENDER

40

Ordering Information : Instruments :

SCC110-1531 IN-SITU BENDER (L)

SCC110-1541

IN-SITU BENDER (R)

41

Ordering Information : Instruments :

SCC110-1711 ROD PUSHER

SCC110-1810

ROD FORK (Adjustable)

42

Ordering Information : Instruments :

SCC110-2911 ANTI-TORQUE WRENCH

SCC110-1920

PERSUADER

SCC110-2430

SCREW HOLDER

43

Ordering Information : Instruments :

SCC110-2811 DISTRACTOR

SCC110-2711

COMPRESSOR

44

Ordering Information : Containers & Trays :

SCC110-0100 Container for instruments

SCC110-0105

Instrument tray 1

SCC110-0106

Instrument tray 2

45

Ordering Information : Trays :

SCC110-0102 TRAY RODS 1 (INCL. COVERING PLATE)

SCC110-0103

TRAY HOOKS 2 (INCL. COVERING PLATE)

46

Ordering Information : Containers & Trays :

SCC110-0101 Container for spinal implants

SCC110-0104

Screw caddy

47

Ordering Information : Lid :

SCC110-0107 SPARE-LID (FOR SCC 110-0102 / 0103)

48

Rev.1.00

49