SMR Shoulder
SMR Shoulder - Humeral Body 140° Finned Reverse
5manufacturers in China registered for this device type
20catalogue numbers in this listing
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 | Limacorporate, Italy |
|---|---|
| FDA product code | MBF |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3670 |
| 510(k) | K163397 |
| Record published | 2020-04-24 |
| Record revised | 2024-10-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9013.75.399 | In distribution | |
| 9013.75.872 | In distribution | |
| 9013.74.334 | +4 mm | In distribution |
| 1352.15.011 | 140° | In distribution |
| 9013.75.343 | SMALL-R # LONG | In distribution |
| 9013.74.332 | +2 mm | In distribution |
| 9013.75.877 | Superior-Left 10° | In distribution |
| 9013.75.885 | Posterior 15° | In distribution |
| 9013.75.332 | 10° | In distribution |
| 1352.15.015 | 140° Short | In distribution |
| 9013.75.365 | 7° | In distribution |
| 9013.75.875 | Superior-Left 7° | In distribution |
| 9013.75.881 | Superior-Left 19° | In distribution |
| 9013.75.879 | Superior-Left 15° | In distribution |
| 9013.75.355 | In distribution | |
| 9013.75.883 | Posterior 7° | In distribution |
| 9013.75.356 | 7° and 10° defects | In distribution |
| 9013.75.393 | In distribution | |
| 1352.15.051 | 140° Finned | In distribution |
| 9013.75.367 | 15° | 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 |
| Comprehensive® SRS | Biomet Orthopedics | 25 |
| Inhance | Depuy (Ireland) | 25 |
| 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
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 |
|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | 510(k) number | 2023-02-21 | Class II | Process control | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation | 1 |
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.