BIO-Modular
3 catalogue numbers from 406540, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K030710 |
| Record published | 2017-03-20 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 406540 | 48MM X 24MM | In distribution |
| 406531 | 48MM X 27MM | In distribution |
| 406533 | 44MM X 15MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223631 | 2023-07-12 |
| K023063 | 2002-12-13 |
| K020045 | 2002-01-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2012-11-01 | Class II | Process control | The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead | 4 | 2013-08-29 |
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.