CoLink® NeoFuse
CoLink NeoFuse is an anterior ankle fusion and fracture-fixation system with titanium-alloy plates and screws. The plate construct spans the distal tibia and talus to stabilize the treated…
CoLink NeoFuse is an anterior ankle fusion and fracture-fixation system with titanium-alloy plates and screws. The plate construct spans the distal tibia and talus to stabilize the treated region.
For ankle fusion, an additional compression screw must pass through the tibiotalar joint. This screw is required alongside the plate construct rather than being an optional substitute for it.
Listed Item
Anterior Lateral Fusion Plate, 3-Hole, Right
Construct and Supply
The plates and screws are supplied sterile. NeoFuse is part of the wider CoLink plating family, but its anterior ankle indication and requirement for joint compression define this configuration. A CoLag 6.7 mm screw is one specified example for the compression element.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213069 |
| Record published | 2022-01-21 |
| Record revised | 2026-05-08 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V45 ST740 | In distribution | |
| V45 ST716 | In distribution | |
| V45 ST822 | In distribution | |
| V45 ST750 | In distribution | |
| V45 ST860 | In distribution | |
| P20 ST201 | In distribution | |
| V45 ST620 | In distribution | |
| P20 ST225 | In distribution | |
| V45 ST828 | In distribution | |
| V45 ST855 | In distribution | |
| V45 ST650 | In distribution | |
| V45 ST624 | In distribution | |
| V45 ST765 | In distribution | |
| V45 ST850 | In distribution | |
| V45 ST845 | In distribution | |
| P20 ST235 | In distribution | |
| V45 ST645 | In distribution | |
| V45 ST730 | In distribution | |
| V45 ST728 | In distribution | |
| V45 ST826 | In distribution | |
| P20 ST101 | In distribution | |
| P20 ST133 | In distribution | |
| V45 ST660 | In distribution | |
| V45 ST665 | In distribution | |
| P20 ST125 | In distribution | |
| V45 ST626 | In distribution | |
| V45 ST820 | In distribution | |
| V45 ST818 | In distribution | |
| V45 ST618 | In distribution | |
| V45 ST840 | In distribution | |
| V45 ST622 | In distribution | |
| V45 ST720 | In distribution | |
| V45 ST718 | In distribution | |
| V45 ST632 | In distribution | |
| V45 ST695 | In distribution | |
| V45 ST734 | In distribution | |
| P20 ST233 | In distribution | |
| V45 ST634 | In distribution | |
| V45 ST724 | In distribution | |
| V45 ST736 | In distribution | |
| P20 ST223 | In distribution | |
| V45 ST865 | In distribution | |
| V45 ST745 | In distribution | |
| V45 ST755 | In distribution | |
| V45 ST630 | In distribution | |
| V45 ST832 | In distribution | |
| P20 ST135 | In distribution | |
| V45 ST834 | In distribution | |
| V45 ST675 | In distribution | |
| V45 ST838 | In distribution | |
| V45 ST726 | In distribution | |
| V45 ST760 | In distribution | |
| V45 ST732 | In distribution | |
| V45 ST722 | In distribution | |
| V45 ST670 | In distribution | |
| V45 ST685 | In distribution | |
| V45 ST640 | In distribution | |
| V45 ST636 | In distribution | |
| V45 ST824 | In distribution | |
| P20 ST123 | In distribution | |
| V45 ST600 | In distribution | |
| V45 ST816 | In distribution | |
| V45 ST680 | In distribution | |
| V45 ST738 | In distribution | |
| V45 ST836 | In distribution | |
| V45 ST690 | In distribution | |
| V45 ST616 | In distribution | |
| V45 ST638 | In distribution | |
| V45 ST655 | In distribution | |
| V45 ST628 | In distribution | |
| V45 ST830 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241387 | 2024-08-13 |
| K233089 | 2024-05-24 |
| K213698 | 2022-05-27 |
| K213069 | 2021-12-13 |
| K212487 | 2021-11-18 |
| K210060 | 2021-03-12 |
| K201149 | 2020-07-15 |
| K200762 | 2020-04-23 |
| K193543 | 2020-01-17 |
| K190385 | 2019-08-08 |
| K191535 | 2019-07-29 |
| K182402 | 2018-09-27 |
| K181113 | 2018-06-15 |
| K172300 | 2017-11-27 |
| K170518 | 2017-07-14 |
| K163293 | 2017-05-05 |
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.