Duraloc
DURALOC ACETABULAR CUP SYSTEM ENDURON BANTAM ACETABULAR LINER 10 DEGREE 22.225mm ID 46mm OD
3manufacturers in China registered for this device type
1catalogue number
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) | K944538 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-13 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1241-46-526 | In distribution |
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 |
| AMK | Depuy Orthopaedics, Inc. | 8 |
| RHS – Radial Prosthesis | Tornier Inc. | 7 |
| AML TRI-Lock | Depuy Orthopaedics, Inc. | 2 |
| Acclaim | Depuy Orthopaedics, Inc. | 2 |
| Elite | Depuy Intl., Ltd. | 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.