Bio-Modular® Shoulder System
45 catalogue numbers from 113930, 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
45catalogue 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) | K030710 |
| Record published | 2018-07-23 |
| 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 |
|---|---|---|
| 113930 | Small | In distribution |
| 113736 | 44MM HEAD Ø 22MM HEIGHT | In distribution |
| 113764 | 44MM HEAD Ø 17MM HEIGHT | In distribution |
| CP550685 | 9 MM 115MM LENGTH | In distribution |
| 113896 | 54 MM 24 MM | In distribution |
| 113933 | MEDIUM | In distribution |
| 113924 | 48 MM 19 MM | In distribution |
| 113940 | SMALL SIZE 10° | In distribution |
| 11-113700 | 6 MM 115 MM | In distribution |
| 113769 | 48mm Head ø 19mm Height | In distribution |
| 11-113708 | 12 MM 115 MM | In distribution |
| CP550133 | 54MM Ø 19MM HEIGHT | In distribution |
| 11-113702 | 6 MM 70 MM | In distribution |
| 11-113731 | 15 MM 70 MM | In distribution |
| 113942 | MEDIUM SIZE 10° | In distribution |
| 113929 | 54 MM 27 MM | In distribution |
| 113872 | MEDIUM SIZE 4 MM | In distribution |
| 11-113723 | 7 MM 70 MM | In distribution |
| 113923 | 44 MM 27 MM | In distribution |
| CP550686 | 11 MM 115MM LENGTH | In distribution |
| 113927 | 54 MM 22 MM | In distribution |
| 113760 | 40MM HEAD Ø 15MM HEIGHT | In distribution |
| 113925 | 48 MM 24 MM | In distribution |
| CP550454 | 56MM Ø 22MM HEIGHT | In distribution |
| CP550731 | 56MM Ø 24MM HEIGHT | In distribution |
| 113763 | 44MM HEAD Ø 15MM HEIGHT | In distribution |
| 113794 | 11MM Ø | In distribution |
| 113740 | 48mm Head ø 24mm Height | In distribution |
| 113928 | 54 MM 24 MM | In distribution |
| 113771 | 48MM HEAD Ø 27MM HEIGHT | In distribution |
| 11-113707 | 11 MM 115 MM | In distribution |
| 11-113710 | 14 MM 115 MM | In distribution |
| 113852 | MEDIUM SIZE 7 MM | In distribution |
| 113888 | 44 MM 27 MM | In distribution |
| 11-113728 | 12 MM 70 MM | In distribution |
| 113882 | 40 MM 20 MM | In distribution |
| 113944 | Large Size 10° | In distribution |
| 113932 | Small Size 6 mm | In distribution |
| 113892 | 48 MM 24 MM | In distribution |
| 113797 | 14MM Ø | In distribution |
| 113880 | 40 MM 15 MM | In distribution |
| 113732 | 40MM HEAD Ø 20MM HEIGHT | In distribution |
| 113945 | LARGE SIZE 10° | In distribution |
| 113771 | 48mm Head ø 27mm Height | In distribution |
| 113941 | SMALL SIZE 10° | 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
2 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 | 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.