BIO-Modular Shoulder System
41 catalogue numbers from 11-113724, 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
41catalogue 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) | K030710 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-113724 | 8 MM 70 MM | In distribution |
| CP550734 | 58MM Ø 22MM HEIGHT | In distribution |
| 11-113730 | 14 MM 70 MM | In distribution |
| CP550733 | 56MM Ø 27MM HEIGHT | In distribution |
| 113738 | 44MM HEAD Ø 27MM HEIGHT | In distribution |
| 113921 | 44 mm 17 mm | In distribution |
| 113937 | Large Size 4 mm | In distribution |
| 113768 | 44MM HEAD Ø 27MM HEIGHT | In distribution |
| 113865 | MEDIUM | In distribution |
| 11-113705 | 9 MM 115 MM | In distribution |
| 113890 | 48 MM 19 MM | In distribution |
| 113942 | Medium Size 10° | In distribution |
| 113853 | LARGE SIZE 4 MM | In distribution |
| 113762 | 40mm Head ø 20mm Height | In distribution |
| 113928 | 54 mm 24 mm | In distribution |
| CP550732 | 56MM Ø 22MM HEIGHT | In distribution |
| 113943 | MEDIUM SIZE 10° | In distribution |
| 113934 | MEDIUM SIZE 4 MM | In distribution |
| 113925 | 48 mm 24 mm | In distribution |
| 113941 | Small Size 10° | In distribution |
| 113894 | 54 mm 22 mm | In distribution |
| 113890 | 48 mm 19 mm | In distribution |
| 113884 | 44 MM 17 MM | In distribution |
| 113841 | In distribution | |
| 113924 | 48 mm 19 mm | In distribution |
| 113937 | LARGE SIZE 4 MM | In distribution |
| 113936 | LARGE | In distribution |
| 113867 | LARGE | In distribution |
| 113927 | 54 mm 22 mm | In distribution |
| 113764 | 44mm Head ø 17mm Height | In distribution |
| 113892 | 48 mm 24 mm | In distribution |
| 11-113711 | 15 MM 115 MM | In distribution |
| 113766 | 44MM HEAD Ø 22MM HEIGHT | In distribution |
| 113884 | 44 mm 17 mm | In distribution |
| 113711 | In distribution | |
| 113938 | Large Size 6 mm | In distribution |
| 113772 | 54MM HEAD Ø 22MM HEIGHT | In distribution |
| 113929 | 54 mm 27 mm | In distribution |
| 113938 | LARGE SIZE 6 MM | In distribution |
| 113711 | In distribution | |
| 113863 | SMALL | 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 |
| 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 |
| 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
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2019-08-21 | Class II | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 214741 | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| 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.