3. 1
Table of contents :
Introduction Universal Pedicular Screw System 2
Product feature 3-4
Indications & Contraindications 5
Ordering information Implants 14-48
Mono-Axial Screws (Reduction) 14-15
Mono-Axial Screws (non-Reduction) 16-17
Poly-Axial Screws (Reduction) 18-19
Poly-Axial Screws (non-Reduction) 20-21
Set screw & Crosslinks 22
Dynamic Poly-Axial Screws (Reduction) 23-24
Dynamic Poly-Axial Screws (non-Reduction) 25-26
Rods 27-28
Hooks 29-32
Instruments 33-44
Containers & Trays 45-48
Surgical Technique Surgical Technique 6 - 13
Step 1 : Creating a screws hole 6
Step 2 : Radiographic control 7
Step 3 : Tapping 7
Step 4 : Screws insertion 8
Step 5 : Bending and attaching the rods 8
Step 6 : Rod placement 9
Step 7 : Insert the set screws 10
Step 8 : Insert the set screws(2) 11
Step 9 : Distraction / Compression 12
Step 10 : Tightening of the set screws 13
4. 2
Introduction :
Key Features & Benefits :
Universal Pedicular Screw System
Screw,hooks,rods and clamps
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.
The Spinal System is a set of instruments and implants for the surgical ap-
proaches of deformity, degenerative and trauma indications.
Universal Pedicular Screw System
The Spinal System is a set of instruments and implants for the surgical ap
5. 3
Product features
Pedicular Screw :
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
Non-Reduction Screw
Screw heads are color coded
by screw diameter
Reduction 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.
Screw Shaft
• Self-tapping design
• Diameters are from 4.5mm to 8.5mm
• Increased pull-out strength
• Easy rod capture (50° rom)
4.5mm 5.5mm 6.5mm 7.5mm
Single Piece
Set Screw
(Optional)
Set Screw
The Spinal Fixation System is an internal fixation device for spinal surgery
7. 5
Indications / Contraindications :
Indications
Contraindications (Contraindications include, but are not limited to) :
1 Degenerative spondylolisthesis
2 Fracture
3 DDD (confirmed by patient history and radiographic studies)
4 Spinal tumors
5 Dislocation
6 Scoliosis
7 Kyphosis
8 Failed previous fusion
9 Having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first
sacral (L5-S1) vertebral joint
10 Who are receiving fusions using autogenous bone graft only
11 Who are having the device fixed or attached to the lumbar and sacral spine
(L3 and below)
12 Who are having the device removed after the development of a solid
fusion mass
1 Active infectious process or significant risk of infection (immunocompromise)
2 Signs of local inflammation
3 Fever or leukocytosis
4 Morbid obesity
5 Pregnancy
6 Mental illness
7 Grossly distorted anatomy caused by congenital abnormalities.
8 Any other medical or surgical condition which would preclude the potential
benefit of spinal implant surgery.
9 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.
10 Suspected or documented metal allergy or intolerance.
11 Any case not needing a bone graft and fusion.
12 Any case where the implant components selected for use would be too large
or too small to achieve a successful result.
13 Any case that requires the mixing of metals from two different components
or systems.
14 Any patient having inadequate tissue coverage over the operative site or
inadequate bone stock or quality.
15 Any patient in which implant utilization would interfere with anatomical
structures or expected physiological performance.
16 Any patient unwilling to follow postoperative instructions.
When used as a fixation system of the non-cervical posterior spine in skeletally mature patients,
the
When used as a fixation system of the non-cervical posterior spine in skeletally mature patients,
Spine System is indicated for one or more of the following:
8. 6
Confirm by using the Tester whether the
created screw hole has deviated out of the bone or not.
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
TESTER SCC110-0410
Surgical Technique :
Step 1 : Creating a screw hole
Instrument :
SCC110-0211 AWL
SCC110-0311 Probe(Straight)
SCC110-0410 Tester
Insert the pedicle probe into the hole , and gently
push it into the pedicle.
PROBE (STRAIGHT)
SCC110-0311
9. 7
Step 2 : Radiograhic control
Instrument :
SCC110-0110 Guide Pin 100mm
SCC110-0120 Guide Pin 100mm w.Stop
When implementing radiographic control meas-
ures, use the pedicle marker.
Step 3 : Tapping
Instrument :
SCC110-0540/C Tap 4.5mm
SCC110-0550/C Tap 5.5mm
SCC110-0560/C Tap 6.5mm
SCC110-0570/C Tap 7.5mm
SCC110-0580/C Tap 8.5mm
SCC110-0410 Tester
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.
GUIDE PIN 100 SCC110-0110
GUIDE PIN 100+STOP SCC110-0120
TAP SCC110-0XXX
TESTER SCC110-0410
Surgical Technique :
10. 8
Step 5 : Bending and attaching the rod
Instrument :
SCC110-1520 French Bender
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 connec-
tion, bend the rod appropriately. ( see fig I , II , III )
This operation is particularly Important when using
the monoaxial screw.
Step 4 : Screw insertion
Instrument :
SCC110-0951 Polyaxial Screw Driver Shaft
SCC110-0955 Monoaxial Screw driver Shaft
SCC110-2425 M Screw driver (Medium)
SCC110-0951C Polyaxial Screw Driver Shaft , Cannulated
SCC110-0955C Monoaxial Screw driver Shaft , Cannulated
Attach the screwdriver to the screw. The screw-
driver 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.
Fig. I Fig. II Fig. III
FRENCH BENDER
SCC110-1520
Surgical Technique :
POLYAXIAL SCREWDRIVER SHAFT SCC110-0951/C
SCREWDRIVER (MEDIUM) SCC110-2425M
MONOAXIAL SCREWDRIVER SHAFT SCC110-0955/C
11. 9
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 :
12. 10
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.
This operation to push the rod into the screw
bottom is especially important when using the
monoaxial screw.
Self holding
Fig. I Fig. II
ROD PUSHER
SCC110-1711
ROD FORK
SCC110-1810
Surgical Technique :
13. 11
Step 8 : Insert the Set Screw(2)
Instrument :
SCC 110-1711 Rod Pusher
SCC 110-1810 Rod Fork
SCC 110-1920 Persuader
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.
Fig. I Fig. II
ROD PUSHER
SCC110-1711
PERSUADER
SCC110-1920
ROD FORK (Adjustable)
SCC110-1810
Surgical Technique :
14. 12
Surgical Technique :
Step 9 : Compression / Distraction
Instrument :
SCC110-2711 Compressor
SCC110-1311 Rod Clamp
SCC110-2811 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 proci-
sionally tighten the set screw. Once distraction is
achieved in all levels final tighten all set screws.
Final tightening illustrated in step 10
Compressor
SCC110-2711
Rod camp
SCC110-1311
Distractor
SCC110-2811
15. 13
Step 10 : Tightening of the Set Screw
Instrument :
SCC110-2441 T-handle(Torque-limiter)
SCC110-2420 S Screw driver (small)
SCC110-2425 M Screw driver (medium)
SCC110-2430 L Screw driver (Large)
SCC110-2911 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
Surgical Technique :
20. 18
Implants :
Poly-Axial Screw 4.5mm Reduction
PSR 08-4520 20mm
PSR 08-4525 25mm
PSR 08-4530 30mm
PSR 08-4535 35mm
PSR 08-4540 40mm
PSR 08-4545 45mm
PSR 08-4550 50mm
PSR 08-4555 55mm
PSR 08-4560 60mm
Poly-Axial Screw 5.5mm Reduction
PSR 09-5520 20mm
PSR 09-5525 25mm
PSR 09-5530 30mm
PSR 09-5535 35mm
PSR 09-5540 40mm
PSR 09-5545 45mm
PSR 09-5550 50mm
PSR 09-5555 55mm
PSR 09-5560 60mm
Ordering Information :
Poly-Axial Reduction Screws :
21. 19
Ordering Information :
Poly-Axial Reduction Screws :
Implants :
Poly-Axial Screw 6.5mm Reduction
PSR 10-6520 20mm
PSR 10-6525 25mm
PSR 10-6530 30mm
PSR 10-6535 35mm
PSR 10-6540 40mm
PSR 10-6545 45mm
PSR 10-6550 50mm
PSR 10-6555 55mm
PSR 10-6560 60mm
Poly-Axial Screw 7.5mm Reduction
PSR 11-7520 20mm
PSR 11-7525 25mm
PSR 11-7530 30mm
PSR 11-7535 35mm
PSR 11-7540 40mm
PSR 11-7545 45mm
PSR 11-7550 50mm
PSR 11-7555 55mm
PSR 11-7560 60mm
24. 22
Ordering Information :
Set screw and Cross-Link :
Set screw
CHM01-10 With Saddle
CHM01-12 Without Saddle
Crosslink
SCC0120-0035
Range
40-45 mm
SCC0120-0042 45-55 mm
SCC0120-0050 55-65 mm