True Spinal Fixation System
The True polyaxial pedicle screw is an implant component of a rod-based spinal fixation system. It anchors the construct to the spine for posterior stabilization from the thoracic region…
The True polyaxial pedicle screw is an implant component of a rod-based spinal fixation system. It anchors the construct to the spine for posterior stabilization from the thoracic region through the sacrum in skeletally mature patients, as an adjunct to spinal fusion.
The system combines polyaxial pedicle screws with longitudinal rods and rod-to-rod connectors. The screw acts as an anchor within this linked construct, helping immobilize the treated spinal region. True system implants are made from Ti-6Al-4V ELI titanium alloy.
Listed Item
7.5mm x 35mm True Polyaxial Pedicle Screw
Treatment Scope
The system is used for specified spinal instabilities and deformities, including fractures, spinal stenosis, scoliosis, pseudarthrosis and failed previous fusion. It is intended for noncervical fixation.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Innovative Surgical Designs, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K133690 |
| Record published | 2017-03-09 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 25 to 559 mm; outer diameter 5.5 to 7.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N-105-9-303-067 | Length 67 mm | In distribution |
| N-105-9-303-062 | Length 62 mm | In distribution |
| 105-9-309-735 | Length 35 mm | In distribution |
| 105-9-307 | In distribution | |
| 105-9-309-530 | Length 30 mm | In distribution |
| 105-9-309-650 | Length 50 mm | In distribution |
| 105-9-309-740 | Length 40 mm | In distribution |
| 105-9-318-SP | In distribution | |
| 105-9-318-SL | In distribution | |
| 105-9-320-620 | Outer Diameter 6.5 mm | In distribution |
| 105-9-309-545 | Length 45 mm | In distribution |
| N-105-9-331-04 | In distribution | |
| N-105-9-303-525 | Length 25 mm | In distribution |
| N-105-9-303-095 | Length 95 mm | In distribution |
| N-105-9-337-02 | Length 65 mm | In distribution |
| 105-9-309-525 | Length 25 mm | In distribution |
| 105-9-309-640 | Length 40 mm | In distribution |
| 105-9-309-540 | Length 40 mm | In distribution |
| N-105-9-303-090 | Length 90 mm | In distribution |
| 105-9-329-495 | Length 495 mm | In distribution |
| N-105-9-303-535 | Length 35 mm | In distribution |
| N-105-9-303-080 | Length 80 mm | In distribution |
| 105-9-318-CP | In distribution | |
| N-105-9-303-085 | Length 85 mm | In distribution |
| N-105-9-303-550 | Length 50 mm | In distribution |
| 105-9-305 | In distribution | |
| 105-9-309-750 | Length 50 mm | In distribution |
| 105-9-309-745 | Length 45 mm | In distribution |
| N-105-9-303-547 | Length 47 mm | In distribution |
| N-105-9-303-047 | Length 47 mm | In distribution |
| 105-9-309-645 | Length 45 mm | In distribution |
| N-105-9-303-072 | Length 72 mm | In distribution |
| N-105-9-303-105 | Length 105 mm | In distribution |
| N-105-9-303-537 | Length 37 mm | In distribution |
| N-105-9-303-030 | Length 30 mm | In distribution |
| N-105-9-303-527 | Length 27 mm | In distribution |
| N-105-9-303-545 | Length 45 mm | In distribution |
| N-105-9-303-530 | Length 30 mm | In distribution |
| 105-9-320-720 | Outer Diameter 7.5 mm | In distribution |
| 105-9-329-267 | Length 267 mm | In distribution |
| N-105-9-303-055 | Length 55 mm | In distribution |
| N-105-9-303-065 | Length 65 mm | In distribution |
| N-105-9-303-100 | Length 100 mm | In distribution |
| N-105-9-303-045 | Length 45 mm | In distribution |
| 105-9-309-635 | Length 35 mm | In distribution |
| 105-9-309-A60 | Length 49 mm | In distribution |
| 105-9-309-550 | Length 50 mm | In distribution |
| 105-9-318-MI | In distribution | |
| N-105-9-303-540 | Length 40 mm | In distribution |
| N-105-9-331 | In distribution | |
| N-105-9-303-070 | Length 70 mm | In distribution |
| 105-9-320-520 | Outer Diameter 5.5 mm | In distribution |
| 105-9-322 | In distribution | |
| N-105-9-303-050 | Length 50 mm | In distribution |
| N-105-9-337-01 | Length 45 mm | In distribution |
| 105-9-309-535 | Length 35 mm | In distribution |
| 105-9-329-559 | Length 559 mm | In distribution |
| N-105-9-303-532 | Length 32 mm | In distribution |
| N-105-9-303-052 | Length 52 mm | In distribution |
| 105-9-318-CL | In distribution | |
| N-105-9-303-075 | Length 75 mm | In distribution |
| N-105-9-303-060 | Length 60 mm | In distribution |
| N-105-9-303-542 | Length 42 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133690 | 2014-05-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.