Comprehensive® SRS
25 catalogue numbers from 110029825, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBF |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3670 |
| 510(k) | K153398 |
| Record published | 2017-03-16 |
| 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 |
|---|---|---|
| 110029825 | Left 60 mm | In distribution |
| 211234 | Ø14 mm 75mm Length | In distribution |
| 211227 | 120 MM | In distribution |
| 211261 | Ø9 mm 200 mm Length | In distribution |
| 211269 | Small | In distribution |
| 211242 | Ø8 mm 150 mm Length | In distribution |
| 211306 | 17 MM 200 MM | In distribution |
| 211268 | Large Size | In distribution |
| 211249 | Ø12 mm 200 mm Length | In distribution |
| 211286 | 13 MM 75 MM | In distribution |
| 211250 | 50 MM | In distribution |
| 405234 | 3.5 mm | In distribution |
| 211216 | Small 58 mm | In distribution |
| 110029826 | Left 70 mm | In distribution |
| 211303 | 13 MM 200 MM | In distribution |
| 211302 | 7 MM 200 MM | In distribution |
| 211262 | Ø11 mm 75 mm Length | In distribution |
| 211282 | Ø18 mm 100 mm Length | In distribution |
| 211271 | In distribution | |
| 211283 | Ø16 mm 150 mm Length | In distribution |
| 211253 | 50 MM | In distribution |
| 211244 | Ø12 mm 150 mm Length | In distribution |
| 211295 | 7 MM 150 MM | In distribution |
| 211235 | Ø6 mm 100mm Length | In distribution |
| 211257 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 181 |
| Shoulder Innovations Humeral Short Stem System | Shoulder Innovations, Inc | 87 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 70 |
| BIO-Modular Shoulder System | Biomet Orthopedics | 41 |
| Shoulder Innovations InSet 95 Humeral Stem | Shoulder Innovations, Inc | 40 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 36 |
| Identity™ | Zimmer, Inc. | 29 |
| Inhance | Depuy (Ireland) | 25 |
| SMR Shoulder | Limacorporate | 20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Synthes (U.S.A.) LP | 19 |
| BI-Angular System | Biomet Orthopedics | 16 |
| Global Unite | Depuy (Ireland) | 16 |
Showing 12 of 71. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112905 | 2012-05-24 |
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.