Solar
Bearing and Axle Bushing Assembly Standard Elbow
1manufacturer
27catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K980502 |
| Record published | 2023-06-23 |
| Record revised | 2025-03-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2021-12-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C-MM100315-00 | In distribution | |
| 5005-012L | Size: Standard | In distribution |
| 5005-013L | Side: LEFT | In distribution |
| 5005-302L | Size: LGE | In distribution |
| C-MM100328-00 | In distribution | |
| C-MM100315-03 | In distribution | |
| C-MM100315-02 | In distribution | |
| 5005-2040 | Size: Standard | In distribution |
| 5005-002L | Size: Standard | In distribution |
| C-MM100328-01 | In distribution | |
| 5005-012R | Size: Standard | In distribution |
| C-M110-1-201 | Size: Standard | In distribution |
| 5005-002R | Size: Standard | In distribution |
| 5005-003R | Size: LGE | In distribution |
| C-M109-7-401 | Size: Standard | In distribution |
| 5005-102L | Size: SM | In distribution |
| 5005-3035 | Size: LGE | In distribution |
| 5005-013R | Side: RIGHT | In distribution |
| 5005-102R | Side: RIGHT | In distribution |
| 5005-302R | Size: LGE | In distribution |
| C-M110-1-200 | Size: Standard | In distribution |
| 5005-202L | Size: Standard | In distribution |
| C-MM100315-01 | In distribution | |
| C-M109-7-400 | Size: Standard | In distribution |
| 5005-2035 | Size: Standard | In distribution |
| 5005-202R | Side: RIGHT | Withdrawn |
| 5005-003L | Side: LEFT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Tema Elbow | Limacorporate | 72 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Prosthesis, Elbow, Constrained, Cemented | Zimmer, Inc. | 37 |
| Latitude™ EV | Tornier Inc. | 36 |
| Comprehensive® SRS | Biomet Orthopedics | 31 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 30 |
| Zimmer® Nexel® Total Elbow | Zimmer, Inc. | 23 |
| Arrow | Teleflex Medical LLC | 13 |
Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US |
| Howmedica Osteonics Corp | UDI-DI | 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US |
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.