The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System consists of longitudinal members (rods), anchors (hooks and screws), interconnections (cross connector) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2 / Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
Proposed Trade Name: SurgTech Thoraco-lumbo-sacral (TLS) Posterior Fixation System
Common Name: Posterior Pedicle Screw and Hook System
Regulatory Class: Class II
Regulatory Name and Number: Thoraco-lumbo-sacral pedicle screw system, 21 CFR 888.3070, NKB
Product Code: Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050, KWP
Materials: SurgTech TLS System is manufactured from titanium alloys (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-7Nb per ASTM F1295).
SurgTech TLS System Class II Device-specific Instruments
1. Tap for Screw (Ø4.5/Ø5.0/Ø5.5/Ø6.0/Ø6.5/Ø7.0) 2. Monoaxial Pedicle Screwdriver 3. Polyaxial Pedicle Screwdriver 4. L-handle Countertorque 5. Cross-connector Placement Forceps 6. Case & Tray 7. Screw Caddy 8. Hook Caddy
SurgTech TLS System Class I Instruments
1. Awl 2. Pedicle Probes (Straight) 3. Pedicle Probes (Curved) 4. Pedicle Probes (Narrow) 5. Pedicle Marker Holder 6. Pedicle Marker (Cylindrical) 7. Pedicle Marker (Spherical) 8. Pedicle Sounder (Straight) 9. Pedicle Sounder (Curved) 10. Provisional Tightening Wrench T30/T25 11. Modular Screwdriver Short 1/4'' Sq T25 12. Modular Screwdriver Short 1/4'' Sq T30 13. Modular Screwdriver Long 1/4'' Sq T25 14. Modular Screwdriver Long 1/4'' Sq T30 15. Tulip Forceps / Rocker 16. Universal Rod Bender 17. In Situ Rod Bender 18. Rod Forceps 19. Rod Gripper 20. Rod Template Ø5.5*LLmm (100*300) 21. Rod Reducer 22. Rod Pusher 23. Reduction Screw Tab Breaker 24. Parallel Compressor 25. Parallel Distractor 26. Cross-connector Plug Driver 27. Pedicle Elevator/Finder 28. Laminar Elevator/Finder 29. Hook Pusher Inserter 30. Hook Starter 31. Modular Straight Handle, 1/4'' Sq 32. Combined Torque-limiting Straight, 1/4 SQ (CC & Screw Set) 33. Modular T-handle, 1/4'' Sq 34. Torque-limiting T-handle, 1/4'' Sq (Bone Screw) 35. Torque-limiting T-handle, 1/4'' Sq (CrossCon)
The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2 / Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion).
Segmental Instability Of Spine Caused By Degenerative Diseases
Stenosis Of Spinal Canal
Tumors And Tuberculosis Of Thoracolumbar Spine
Failure Of Surgical Fusion For Thoracolumbar Spine Diseases
Traumatic Vertebral Fracture And Dislocation