Comprehensive SRS
28 catalogue numbers from 211229, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K111746 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 211229 | LARGE SIZE | In distribution |
| 211225 | 60 MM | In distribution |
| 211279 | Ø54 mm 22 mm Height | In distribution |
| 211241 | Ø6 mm 150mm Length | In distribution |
| 405232 | In distribution | |
| 211217 | Small 68 mm | In distribution |
| 211264 | Ø11 mm 150 mm Length | In distribution |
| 211300 | 4 MM 200 MM | In distribution |
| 211278 | Ø48 mm 19 mm Height | In distribution |
| 211270 | Large | In distribution |
| 211301 | 5 MM 200 MM | In distribution |
| 211232 | Ø10 mm 75mm Length | In distribution |
| 405192 | 44 mm X 17 mm | In distribution |
| 211298 | 17 MM 150 MM | In distribution |
| 211252 | 70 MM | In distribution |
| 211259 | Ø9 mm 100 mm Length | In distribution |
| 211226 | 90 MM | In distribution |
| 110029824 | Left 50 mm | In distribution |
| 211240 | Ø4 mm 150mm Length | In distribution |
| 211256 | Ø40 mm 15 mm Height | In distribution |
| 211260 | Ø9 mm 150 mm Length | In distribution |
| 211307 | 18 MM 200 MM | In distribution |
| 110029939 | Right 60 mm | In distribution |
| 211296 | 13 MM 150 MM | In distribution |
| 405142 | 40 mm X 15 mm | In distribution |
| 211274 | Ø16 mm 75 mm Length | In distribution |
| 211255 | 70 MM | In distribution |
| 211258 | Ø9 mm 75 mm Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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 | 2018-02-28 | Class II | Under Investigation by firm | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly | 634 | 2020-08-11 |
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.