GII
The GII Spinal Fixation System is a posterior spinal fixation system built around top-loading polyaxial pedicle screws used with rods and crosslinks. The FDA filing specifically describes…
The GII Spinal Fixation System is a posterior spinal fixation system built around top-loading polyaxial pedicle screws used with rods and crosslinks. The FDA filing specifically describes the addition of flexStaas pedicle screws to the GII system.
Its stated role is immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical posterior spine. The filing names thoracic, lumbar and sacral use and describes titanium-alloy components in the system.
Listed Item
flexStaas poly axial screw
System Scope
The summary identifies the flexStaas screws as the subject components and reports dynamic flexion-extension and screw/screwdriver torsional testing. The system is intended to be used with autograft and/or allograft. The quoted scope follows the GII filing and does not extend the claim to unrelated implants.
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 | Coligne AG, Switzerland |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K210306 |
| Record published | 2021-07-01 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83.880 | In distribution | |
| 20.036.650 | In distribution | |
| 83.8100 | In distribution | |
| 83.535 | In distribution | |
| 83.530 | In distribution | |
| 83.835 | In distribution | |
| 83.655 | In distribution | |
| 20.036.750 | In distribution | |
| 83.845 | In distribution | |
| 83.745 | In distribution | |
| 20.036.735 | In distribution | |
| 83.650 | In distribution | |
| 83.635 | In distribution | |
| 83.740 | In distribution | |
| 83.730 | In distribution | |
| 20.036.740 | In distribution | |
| 83.890 | In distribution | |
| 83.850 | In distribution | |
| 20.036.730 | In distribution | |
| 20.036.635 | In distribution | |
| 83.860 | In distribution | |
| 20.036.555 | In distribution | |
| 83.550 | In distribution | |
| 20.036.540 | In distribution | |
| 83.640 | In distribution | |
| 83.8120 | In distribution | |
| 20.036.545 | In distribution | |
| 20.036.630 | In distribution | |
| 83.770 | In distribution | |
| 20.036.645 | In distribution | |
| 83.555 | In distribution | |
| 83.735 | In distribution | |
| 20.036.530 | In distribution | |
| 83.870 | In distribution | |
| 83.660 | In distribution | |
| 83.645 | In distribution | |
| 83.760 | In distribution | |
| 83.750 | In distribution | |
| 20.036.745 | In distribution | |
| 83.540 | In distribution | |
| 83.545 | In distribution | |
| 20.036.550 | In distribution | |
| 83.002 | In distribution | |
| 20.036.640 | In distribution | |
| 83.755 | In distribution | |
| 83.630 | In distribution | |
| 20.036.535 | In distribution | |
| 83.8110 | In distribution | |
| 83.840 | 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 |
|---|---|
| K210306 | 2021-05-19 |
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.