AMK
AMK TOTAL KNEE SYSTEM TIBIAL INSERT FIXED BEARING CONSTRAINED SIZE 4 14mm
3manufacturers in China registered for this device type
8catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | JDB |
| Device type | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K864671 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-04 (version 5) |
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 |
| Distribution end date | 2024-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1688-63-025 | In distribution | |
| 1688-71-025 | In distribution | |
| 1688-34-025 | In distribution | |
| 1688-44-025 | In distribution | |
| 1688-61-025 | In distribution | |
| 1688-35-025 | In distribution | |
| 1488-29-025 | Withdrawn | |
| 1488-83-025 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tema Elbow | Limacorporate | 90 |
| Rhead | Stryker GmbH | 46 |
| Latitude EV™ | Tornier Inc. | 33 |
| Latitude™ – Elbow | Tornier Inc. | 22 |
| UNI-Elbow | Stryker GmbH | 20 |
| Tema Elbow System | Limacorporate | 9 |
| Sorbie Questor ™ | Wright Medical Technology, Inc. | 9 |
| RHS – Radial Prosthesis | Tornier Inc. | 7 |
| AML TRI-Lock | Depuy Orthopaedics, Inc. | 2 |
| Acclaim | Depuy Orthopaedics, Inc. | 2 |
| Elite | Depuy Intl., Ltd. | 1 |
| Latitude | Tornier Inc. | 1 |
Showing 12 of 18. All products under Prosthesis, Elbow, Semi-Constrained, Cemented
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2005-11-08 | Not classified | Other | The ulnar bearing may damage the implant’s polyethylene sleeve such that revision surgery is necessary. | 2006-06-16 |
| 2005-11-08 | Not classified | Other | The ulnar bearing may damage the implant’s polyethylene sleeve such that revision surgery is necessary. | 2006-06-16 |
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.