Bio-Modular® Shoulder System
43 catalogue numbers from 113935, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
43catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 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 |
|---|---|---|
| 113935 | Medium Size 6 mm | In distribution |
| 113882 | 40 mm 20 mm | In distribution |
| 11-113725 | 9 MM 70 MM | In distribution |
| 113795 | 12MM Ø | In distribution |
| 113793 | 10MM Ø | In distribution |
| 113854 | LARGE SIZE 7 MM | In distribution |
| 113796 | 13MM Ø | In distribution |
| 11-113726 | 10 MM 70 MM | In distribution |
| 113940 | Small Size 10° | In distribution |
| 113791 | 8MM Ø | In distribution |
| 113935 | MEDIUM SIZE 6 MM | In distribution |
| 113775 | 54mm Head ø 24mm Height | In distribution |
| 11-113703 | 7 MM 115 MM | In distribution |
| 113849 | SMALL SIZE 4 MM | In distribution |
| 113770 | 48MM HEAD Ø 24MM HEIGHT | In distribution |
| 113880 | 40 mm 15 mm | In distribution |
| 113774 | 54mm Head ø 27mm Height | In distribution |
| 113798 | 15MM Ø | In distribution |
| 113930 | SMALL | In distribution |
| CP550660 | 11 MM 115MM LENGTH | In distribution |
| 113732 | 40mm Head ø 20mm Height | In distribution |
| 113851 | MEDIUM SIZE 4 MM | In distribution |
| 113894 | 54 MM 22 MM | In distribution |
| CP550735 | 58MM Ø 27MM HEIGHT | In distribution |
| 11-113727 | 11 MM 70 MM | In distribution |
| 113922 | 44 mm 22 mm | In distribution |
| 11-113709 | 13 MM 115 MM | In distribution |
| 113734 | 44mm Head ø 17mm Height | In distribution |
| 11-113706 | 10 MM 115 MM | In distribution |
| 113926 | 48 mm 27 mm | In distribution |
| 113934 | Medium Size 4 mm | In distribution |
| 113757 | 40MM HEAD Ø 22MM HEIGHT | In distribution |
| 113762 | 40MM HEAD Ø 20MM HEIGHT | In distribution |
| 113932 | SMALL SIZE 6 MM | In distribution |
| CP550710 | 48MM Ø 22MM HEIGHT | In distribution |
| 113769 | 48MM HEAD Ø 19MM HEIGHT | In distribution |
| 113945 | Large Size 10° | In distribution |
| 11-113800 | 7 MM 190 MM | In distribution |
| 113923 | 44 mm 27 mm | In distribution |
| 113931 | SMALL SIZE 4 MM | In distribution |
| CP550445 | 16 MM 115MM LENGTH | In distribution |
| 11-113802 | 9 MM 190 MM | In distribution |
| 113768 | 44mm Head ø 27mm Height | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Catalyst CSR Shoulder System | Catalyst Orthoscience Inc | 39 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223631 | 2023-07-12 |
| K023063 | 2002-12-13 |
| K020045 | 2002-01-30 |
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.