CoLink™ Afx
The CoLink Afx plate is part of an ankle fixation system used to stabilize fractures and osteotomies of the tibia and fibula. The Afx system is indicated for both pediatric and adult…
The CoLink Afx plate is part of an ankle fixation system used to stabilize fractures and osteotomies of the tibia and fibula. The Afx system is indicated for both pediatric and adult patients.
The system combines bone plates, screws and surgical instruments. Its implant components use titanium alloy and commercially pure titanium, with the plates and screws providing the fixation construct for the ankle.
Listed Item
Posterolateral Fibula Plate, 6-HOLE, Right
Ankle Application
The Afx range is the ankle focused part of the broader CoLink plating family. Its specified use addresses traumatic fractures and surgically created bone cuts in the ankle, rather than extending the plate’s role to every anatomical site covered by the larger family.
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) | K181113 |
| Record published | 2018-08-03 |
| Record revised | 2025-11-20 (version 7) |
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 |
|---|---|---|
| P70 ST103 | In distribution | |
| P70 ST012 | In distribution | |
| P70 ST014 | In distribution | |
| P70 ST003 | In distribution | |
| P70 ST133 | In distribution | |
| P70 ST204 | In distribution | |
| P70 ST205 | In distribution | |
| P70 ST235 | In distribution | |
| P70 ST207 | In distribution | |
| P70 ST109 | In distribution | |
| P70 ST126 | In distribution | |
| P70 ST225 | In distribution | |
| P70 ST105 | In distribution | |
| P70 ST226 | In distribution | |
| P70 ST223 | In distribution | |
| P70 ST006 | In distribution | |
| P70 ST233 | In distribution | |
| P70 ST124 | In distribution | |
| P70 ST107 | In distribution | |
| P70 ST125 | In distribution | |
| P70 ST127 | In distribution | |
| P70 ST224 | In distribution | |
| P70 ST111 | In distribution | |
| P70 ST211 | In distribution | |
| P70 ST213 | In distribution | |
| P70 ST010 | In distribution | |
| P70 ST203 | In distribution | |
| P70 ST004 | In distribution | |
| P70 ST113 | In distribution | |
| P70 ST227 | In distribution | |
| P70 ST209 | In distribution | |
| P70 ST008 | In distribution | |
| P70 ST005 | In distribution | |
| P70 ST104 | In distribution | |
| P70 ST123 | In distribution | |
| P70 ST135 | In distribution | |
| P70 ST016 | 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.