Spinal - Implants - Pedicular screws
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Spine Stabilization, Spinal Fusion, Scoliosis Correction System

Spine Stabilization, Spinal Fusion, Scoliosis Correction System

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Spinal - Implants - Pedicular screws Document Transcript

  • 1. 1
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 4 Product features Cross-Link : Rotaion Translation Angulation
  • 6. 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:
  • 7. 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
  • 8. 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 :
  • 9. 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
  • 10. 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 :
  • 11. 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 :
  • 12. 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 :
  • 13. 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
  • 14. 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 :
  • 15. 14 Implants : Mono-Axial Screw 4.5mm Reduction MSR 08-4520 20mm MSR 08-4525 25mm MSR 08-4530 30mm MSR 08-4535 35mm MSR 08-4540 40mm MSR 08-4545 45mm MSR 08-4550 50mm MSR 08-4555 55mm MSR 08-4560 60mm Mono-Axial Screw 5.5mm Reduction MSR 09-5520 20mm MSR 09-5525 25mm MSR 09-5530 30mm MSR 09-5535 35mm MSR 09-5540 40mm MSR 09-5545 45mm MSR 09-5550 50mm MSR 09-5555 55mm MSR 09-5560 60mm Ordering Information : Mono-Axial Reduction Screws :
  • 16. 15 Implants : Mono-Axial Screw 6.5mm Reduction MSR 10-6520 20mm MSR 10-6525 25mm MSR 10-6530 30mm MSR 10-6535 35mm MSR 10-6540 40mm MSR 10-6545 45mm MSR 10-6550 50mm MSR 10-6555 55mm MSR 10-6560 60mm Mono-Axial Screw 7.5mm Reduction MSR 11-7520 20mm MSR 11-7525 25mm MSR 11-7530 30mm MSR 11-7535 35mm MSR 11-7540 40mm MSR 11-7545 45mm MSR 11-7550 50mm MSR 11-7555 55mm MSR 11-7560 60mm Ordering Information : Mono-Axial Reduction Screws :
  • 17. 16 Implants : Mono-Axial Screw 4.5mm Non-Reduction MSS 08-4520 20mm MSS 08-4525 25mm MSS 08-4530 30mm MSS 08-4535 35mm MSS 08-4540 40mm MSS 08-4545 45mm MSS 08-4550 50mm MSS 08-4555 55mm MSS 08-4560 60mm Mono-Axial Screw 5.5mm Non-Reduction MSS 09-5520 20mm MSS 09-5525 25mm MSS 09-5530 30mm MSS 09-5535 35mm MSS 09-5540 40mm MSS 09-5545 45mm MSS 09-5550 50mm MSS 09-5555 55mm MSS 09-5560 60mm Ordering Information : Mono-Axial Non-Reduction Screws :
  • 18. 17 Implants : Mono-Axial Screw 6.5mm Non-Reduction MSS 10-6520 20mm MSS 10-6525 25mm MSS 10-6530 30mm MSS 10-6535 35mm MSS 10-6540 40mm MSS 10-6545 45mm MSS 10-6550 50mm MSS 10-6555 55mm MSS 10-6560 60mm Mono-Axial Screw 7.5mm Non-Reduction MSS 11-7520 20mm MSS 11-7525 25mm MSS 11-7530 30mm MSS 11-7535 35mm MSS 11-7540 40mm MSS 11-7545 45mm MSS 11-7550 50mm MSS 11-7555 55mm MSS 11-7560 60mm Ordering Information : Mono-Axial Non-Reduction Screws :
  • 19. 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 :
  • 20. 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
  • 21. 20 Implants : Poly-Axial Screw 4.5mm Non-Reduction PSS 08-4520 20mm PSS 08-4525 25mm PSS 08-4530 30mm PSS 08-4535 35mm PSS 08-4540 40mm PSS 08-4545 45mm PSS 08-4550 50mm PSS 08-4555 55mm PSS 08-4560 60mm Poly-Axial Screw 5.5mm Non-Reduction PSS 09-5520 20mm PSS 09-5525 25mm PSS 09-5530 30mm PSS 09-5535 35mm PSS 09-5540 40mm PSS 09-5545 45mm PSS 09-5550 50mm PSS 09-4555 55mm PSS 09-5560 60mm Ordering Information : Poly-Axial Non-Reduction Screws :
  • 22. 21 Ordering Information : Poly-Axial Non-Reduction Screws : Poly-Axial Screw 6.5mm Non-Reduction PSS 10-6520 20mm PSS 10-6525 25mm PSS 10-6530 30mm PSS 10-6535 35mm PSS 10-6540 40mm PSS 10-6545 45mm PSS 10-6550 50mm PSS 10-6555 55mm PSS 10-6560 60mm Poly-Axial Screw 7.5mm Non-Reduction PSS 11-7520 20mm PSS 11-7525 25mm PSS 11-7530 30mm PSS 11-7535 35mm PSS 11-7540 40mm PSS 11-7545 45mm PSS 11-7550 50mm PSS 11-7555 55mm PSS 11-7560 60mm
  • 23. 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
  • 24. 23 Implants : Dynamic Poly-Axial Screw 4.5mm Reduction DPR08-4520 20mm DPR08-4525 25mm DPR08-4530 30mm DPR08-4535 35mm DPR08-4540 40mm DPR08-4545 45mm DPR08-4550 50mm DPR08-4555 55mm DPR08-4560 60mm Dynamic Poly-Axial Screw 5.5mm Reduction DPR09-5520 20mm DPR09-5525 25mm DPR09-5530 30mm DPR09-5535 35mm DPR09-5540 40mm DPR09-5545 45mm DPR09-5550 50mm DPR09-5555 55mm DPR09-5560 60mm Ordering Information : Dynamic Poly-Axial Reduction Screws: Non-fusion
  • 25. 24 Ordering Information : Dynamic Poly-Axial Reduction Screws: Non-fusion Implants : Dynamic Poly-Axial Screw 6.5mm Reduction DPR10-6520 20mm DPR10-6525 25mm DPR10-6530 30mm DPR10-6535 35mm DPR10-6540 40mm DPR10-6545 45mm DPR10-6550 50mm DPR10-6555 55mm DPR10-6560 60mm Dynamic Poly-Axial Screw 7.5mm Reduction DPR11-7520 20mm DPR11-7525 25mm DPR11-7530 30mm DPR11-7535 35mm DPR11-7540 40mm DPR11-7545 45mm DPR11-7550 50mm DPR11-7555 55mm DPR11-7560 60mm
  • 26. 25 Implants : Dynamic Poly-Axial Screw 4.5mm Non-Reduction DPS08-4520 20mm DPS08-4525 25mm DPS08-4530 30mm DPS08-4535 35mm DPS08-4540 40mm DPS08-4545 45mm DPS08-4550 50mm DPS08-4555 55mm DPS08-4560 60mm Dynamic Poly-Axial Screw 5.5mm Non-Reduction DPS09-5520 20mm DPS09-5525 25mm DPS09-5530 30mm DPS09-5535 35mm DPS09-5540 40mm DPS09-5545 45mm DPS09-5550 50mm DPS09-5555 55mm DPS09-5560 60mm Ordering Information : Dynamic Poly-Axial Non-Reduction Screws : Non-fusion
  • 27. 26 Ordering Information : Dynamic Poly-Axial Non-Reduction Screws : Non-fusion Implants : Dynamic Poly-Axial Screw 6.5mm Non-Reduction DPS10-6520 20mm DPS10-6525 25mm DPS10-6530 30mm DPS10-6535 35mm DPS10-6540 40mm DPS10-6545 45mm DPS10-6550 50mm DPS10-6555 55mm DPS10-6560 60mm Dynamic Poly-Axial Screw 7.5mm Non-Reduction DPS11-7520 20mm DPS11-7525 25mm DPS11-7530 30mm DPS11-7535 35mm DPS11-7540 40mm DPS11-7545 45mm DPS11-7550 50mm DPS11-7555 55mm DPS11-7560 60mm
  • 28. 27 Ordering Information : Rod to rod connectors : Implants : Extention connector EC1-0001 Parallel connector PC-1-0001
  • 29. 28 Ti Rod (Straight) SCC02-0040 40mm SCC02-0050 50mm SCC02-0060 60mm SCC02-0070 70mm SCC02-0080 80mm SCC02-0090 90mm SCC02-0100 100mm SCC02-0110 110mm SCC02-0120 120mm SCC02-0130 130mm SCC02-0140 140mm SCC02-0150 150mm SCC02-0160 160mm SCC02-0170 170mm SCC02-0180 180mm SCC02-0190 190mm SCC02-0200 200mm SCC02-0250 250mm SCC02-0300 300mm SCC02-0350 350mm SCC02-0400 400mm SCC02-0500 500mm SCC02-0600 600mm Ordering Information : Rods : Ti rod curved SCC03-0080 80mm SCC03-0120 120mm SCC03-0160 160mm
  • 30. 29 Narrow laminar hook HS21-0504 20mm HS21-0505 21mm HS21-0506 22mm HS21-0507 23mm HS21-0508 24mm HS21-0509 25mm HS21-0510 26mm Pedicle hook HS20-0804 20mm HS20-0805 21mm HS20-0806 22mm HS20-0807 23mm HS20-0808 24mm HS20-0809 25mm HS20-0810 26mm Ordering Information : Hooks :
  • 31. 30 Wide larminar hook HS22-0704 20mm HS22-0705 21mm HS22-0706 22mm HS22-0707 23mm HS22-0708 24mm HS22-0709 25mm HS22-0710 26mm Angled larminar hook HS23-0505 20mm HS23-0507 21mm HS23-0509 22mm HS23-0511 23mm HS22-0505 24mm HS22-0507 25mm HS22-0509 27mm HS22-0511 29mm Ordering Information : Hooks :
  • 32. 31 Laminar hook (Left) HS25-0505 24mm HS25-0507 26mm HS25-0509 28mm HS25-0511 30mm Laminar hook (Right) HS26-0505 24mm HS26-0507 26mm HS26-0509 28mm HS26-0511 30mm Laminar hook w. Extended body HS27-0504 23.5mm HS27-0505 24.5mm HS27-0506 25.5mm HS27-0507 26.5mm HS27-0508 27.5mm HS27-0509 28.5mm HS27-0510 29.5mm Ordering Information : Hooks :
  • 33. 32 Implants : SCC110-0110 GUIDE PIN 100mm SCC110-0120 GUIDE PIN 100mm W.STOP Ordering Information : Instruments : Pins :
  • 34. 33 SCC110-0211 AWL SCC110-0321 PROBE (CURVED) Ordering Information : Instruments :
  • 35. 34 SCC110-0410 TESTER Ordering Information : Instruments : SCC110-0311 PROBE (STRAIGHT)
  • 36. 35 SCC110-0630 T-HANDLE LARGE SCC112-0610 T-HANDLE SMALL SCC110-2441 TORQUE LIMITING T-HANDLE 12 nm Ordering Information : Instruments :
  • 37. 36 SCC110-0640 I-HANDLE SCC110-0641 EXTENDED I-HANDLE Ordering Information : Instruments :
  • 38. 37 TAP : NON-CANNULATED SCC110-0540 4.5mm SCC110-0550 5.5mm SCC110-0560 6.5mm SCC110-0570 7.5mm TAP : CANNULATED SCC110-0540C 4.5mm SCC110-0550C 5.5mm SCC110-0560C 6.5mm SCC110-0570C 7.5mm Rod Template RT-1-0001 200 mm Ordering Information : Instruments :
  • 39. 38 SCC110-0951 SCC110-0955 POLY-AXIAL SCREW DRIVER SHAFT MONO-AXIAL SCREW DRIVER SHAFT SCC110-0951C POLY-AXIAL SCREW DRIVER SHAFT , CANNULATED SCC110-0955C MONO-AXIAL SCREW DRIVER SHAFT , CANNULATED SCC110-2420 S SCREW DRIVER (SMALL) SCC110-2425 M SCREW DRIVER (MEDIUM) SCC110-2430 L SCREW DRIVER (LARGE) SCC110-3311 TRANSVERSE WRENCH TIP Ordering Information : Instruments :
  • 40. 39 SCC110-1211 ROD HOLDER SCC110-1410 CUTTING FORCEP Ordering Information : Instruments :
  • 41. 40 SCC110-1311 ROD CLAMP SCC110-1520 FRENCH BENDER Ordering Information : Instruments :
  • 42. 41 SCC110-1531 IN-SITU BENDER (L) SCC110-1541 IN-SITU BENDER (R) Ordering Information : Instruments :
  • 43. 42 SCC110-1711 ROD PUSHER SCC110-1810 ROD FORK (Adjustable) Ordering Information : Instruments :
  • 44. 43 SCC110-2911 ANTI-TORQUE WRENCH SCC110-1920 PERSUADER SCC110-2430 SCREW HOLDER Ordering Information : Instruments :
  • 45. 44 SCC110-2811 DISTRACTOR SCC110-2711 COMPRESSOR Ordering Information : Instruments :
  • 46. 45 SCC110-0105 Instrument tray 1 SCC110-0106 Instrument tray 2 SCC110-0100 Container for instruments Ordering Information : Containers & Trays :
  • 47. 46 SCC110-0102 TRAY RODS 1 (INCL. COVERING PLATE) SCC110-0103 TRAY HOOKS 2 (INCL. COVERING PLATE) Ordering Information : Trays :
  • 48. 47 SCC110-0104 Screw caddy SCC110-0101 Container for spinal implants Ordering Information : Containers & Trays :
  • 49. 48 SCC110-0107 SPARE-LID (FOR SCC 110-0102 / 0103) Ordering Information : Lid :
  • 50. 4949 Rev.1.00