Patriot Spinal Fixation System
Patriot is a posterior spinal fixation system made up of rods, screws and crosslinks. Its components form a temporary internal support construct for the thoracic, lumbar and sacral spine…
Patriot is a posterior spinal fixation system made up of rods, screws and crosslinks. Its components form a temporary internal support construct for the thoracic, lumbar and sacral spine while bone graft heals during fusion.
The system is used in the non-cervical spine from T1 to S1 in skeletally mature patients. Components are offered in different shapes and sizes to assemble the fixation construct around the selected spinal segments.
Listed Item
Patriot Reduction Screw, 8.0 x 115mm
Fusion Context
Patriot provides stabilization and immobilization as an adjunct to fusion. Its specific indication for severe Grade 3 or 4 spondylolisthesis at L5-S1 requires fusion with autologous bone graft.
15manufacturers in China registered for this device type
134catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Valorus Spine, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K180324 |
| Record published | 2023-07-14 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-01-4545 | In distribution | |
| 10-02-8060 | In distribution | |
| 10-03-0060 | In distribution | |
| 10-02-8080 | In distribution | |
| 10-02-6045 | In distribution | |
| 10-01-5030 | In distribution | |
| 10-01-5040 | In distribution | |
| 10-01-5045 | In distribution | |
| 10-02-5035 | In distribution | |
| 10-01-6030 | In distribution | |
| 10-02-5055 | In distribution | |
| 10-04-0030 | In distribution | |
| 10-02-7040 | In distribution | |
| 10-02-8070 | In distribution | |
| 10-02-5050 | In distribution | |
| 10-03-0150 | In distribution | |
| 10-04-0075 | In distribution | |
| 10-02-6040 | In distribution | |
| 10-02-5045 | In distribution | |
| 10-03-0055 | In distribution | |
| 10-04-0095 | In distribution | |
| 10-03-0600 | In distribution | |
| 10-01-7040 | In distribution | |
| 10-02-4550 | In distribution | |
| 10-03-0110 | In distribution | |
| 10-01-8105 | In distribution | |
| 10-03-0450 | In distribution | |
| 10-02-8095 | In distribution | |
| 10-01-8095 | In distribution | |
| 10-01-4530 | In distribution | |
| 10-04-0090 | In distribution | |
| 10-02-8075 | In distribution | |
| 10-01-4550 | In distribution | |
| 10-01-7050 | In distribution | |
| 10-04-0120 | In distribution | |
| 10-02-7030 | In distribution | |
| 10-03-0090 | In distribution | |
| 10-01-8070 | In distribution | |
| 10-02-8115 | In distribution | |
| 10-02-4540 | In distribution | |
| 10-02-8090 | In distribution | |
| 10-05-5874 | In distribution | |
| 10-03-0045 | In distribution | |
| 10-01-5050 | In distribution | |
| 10-01-8040 | In distribution | |
| 10-02-8065 | In distribution | |
| 10-03-0030 | In distribution | |
| 10-02-7055 | In distribution | |
| 10-01-8055 | In distribution | |
| 10-02-8105 | In distribution | |
| 10-01-8035 | In distribution | |
| 10-01-6060 | In distribution | |
| 10-02-8040 | In distribution | |
| 10-02-8035 | In distribution | |
| 10-01-6040 | In distribution | |
| 10-03-0500 | In distribution | |
| 10-02-7060 | In distribution | |
| 10-04-0070 | In distribution | |
| 10-01-1000 | In distribution | |
| 10-02-8055 | In distribution | |
| 10-05-3242 | In distribution | |
| 10-03-0035 | In distribution | |
| 10-04-0040 | In distribution | |
| 10-04-0045 | In distribution | |
| 10-03-0100 | In distribution | |
| 10-01-5035 | In distribution | |
| 10-03-0080 | In distribution | |
| 10-02-7035 | In distribution | |
| 10-01-8085 | In distribution | |
| 10-04-0035 | In distribution | |
| 10-03-0095 | In distribution | |
| 10-04-0060 | In distribution | |
| 10-05-4258 | In distribution | |
| 10-01-6035 | In distribution | |
| 10-03-0065 | In distribution | |
| 10-02-8050 | In distribution | |
| 10-02-8100 | In distribution | |
| 10-01-7030 | In distribution | |
| 10-03-0040 | In distribution | |
| 10-02-5025 | In distribution | |
| 10-03-0085 | In distribution | |
| 10-04-0050 | In distribution | |
| 10-02-6030 | In distribution | |
| 10-01-4555 | In distribution | |
| 10-01-8050 | In distribution | |
| 10-02-5040 | In distribution | |
| 10-02-8085 | In distribution | |
| 10-02-8045 | In distribution | |
| 10-02-6035 | In distribution | |
| 10-01-5055 | In distribution | |
| 10-02-7050 | In distribution | |
| 10-01-4535 | In distribution | |
| 10-01-8065 | In distribution | |
| 10-01-7055 | In distribution | |
| 10-02-4530 | In distribution | |
| 10-02-4525 | In distribution | |
| 10-01-4525 | In distribution | |
| 10-02-6055 | In distribution | |
| 10-01-8115 | In distribution | |
| 10-04-0055 | In distribution | |
| 10-03-0050 | In distribution | |
| 10-01-4540 | In distribution | |
| 10-01-8100 | In distribution | |
| 10-04-0100 | In distribution | |
| 10-04-0065 | In distribution | |
| 10-02-7045 | In distribution | |
| 10-03-0070 | In distribution | |
| 10-02-6060 | In distribution | |
| 10-01-6055 | In distribution | |
| 10-03-0075 | In distribution | |
| 10-01-6050 | In distribution | |
| 10-01-8110 | In distribution | |
| 10-01-8060 | In distribution | |
| 10-02-4555 | In distribution | |
| 10-01-7045 | In distribution | |
| 10-02-4545 | In distribution | |
| 10-04-0110 | In distribution | |
| 10-04-0080 | In distribution | |
| 10-01-7035 | In distribution | |
| 10-01-6045 | In distribution | |
| 10-01-8090 | In distribution | |
| 10-04-0085 | In distribution | |
| 10-01-8080 | In distribution | |
| 10-02-6050 | In distribution | |
| 10-01-8045 | In distribution | |
| 10-02-5030 | In distribution | |
| 10-01-8075 | In distribution | |
| 10-02-8120 | In distribution | |
| 10-01-5025 | In distribution | |
| 10-01-8120 | In distribution | |
| 10-01-7060 | In distribution | |
| 10-03-0400 | In distribution | |
| 10-02-4535 | In distribution | |
| 10-02-8110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180324 | 2018-04-06 |
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.