B-P Total Shoulder System
B-P Shoulder Modular Humeral Stem W/O Head W/Biocoat & W/Ultracoat - 12 MM
9manufacturers in China registered for this device type
50catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Endotec, Inc., 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) | K904879 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-10 (version 6) |
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 |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C |
| Sizes | Outer diameter 8 to 56 mm; width 0 to 10 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-02-5248 | Outer Diameter 48 mm | In distribution |
| 02-02-5244 | Outer Diameter 44 mm | In distribution |
| 02-02-0456 | Outer Diameter 56 mm | In distribution |
| 02-02-0344 | Outer Diameter 44 mm | In distribution |
| 02-15-0604 | Width 10 mm | In distribution |
| 02-02-0348 | Outer Diameter 48 mm | In distribution |
| 02-02-2348 | Outer Diameter 48 mm | In distribution |
| 02-02-2248 | Width 2.5 mm | In distribution |
| 02-02-2448 | Outer Diameter 48 mm | In distribution |
| 02-04-0110 | Outer Diameter 10 mm | In distribution |
| 02-02-2344 | Outer Diameter 44 mm | In distribution |
| 02-02-0452 | Width 0 mm | In distribution |
| 02-04-0208 | Outer Diameter 8 mm | In distribution |
| 02-02-2456 | Outer Diameter 56 mm | In distribution |
| 02-02-2352 | Outer Diameter 52 mm | In distribution |
| 02-01-0001 | SIZE 1 | In distribution |
| 02-04-0214 | Outer Diameter 14 mm | In distribution |
| 02-04-0114 | Outer Diameter 14 mm | In distribution |
| 02-15-0603 | Width 7.5 mm | In distribution |
| 02-02-2252 | Width 2.5 mm | In distribution |
| 02-04-0348 | Outer Diameter 48 mm | In distribution |
| 02-02-2244 | Width 2.5 mm | In distribution |
| 02-02-5344 | Outer Diameter 44 mm | In distribution |
| 02-02-5348 | Outer Diameter 48 mm | In distribution |
| 02-02-2452 | Outer Diameter 52 mm | In distribution |
| 02-02-0252 | Outer Diameter 52 mm | In distribution |
| 02-02-5452 | Outer Diameter 52 mm | In distribution |
| 02-04-0344 | Outer Diameter 44 mm | In distribution |
| 02-15-0602 | Width 5 mm | In distribution |
| 02-02-5252 | Outer Diameter 52 mm | In distribution |
| 02-02-0444 | Outer Diameter 44 mm | In distribution |
| 02-04-0108 | Outer Diameter 8 mm | In distribution |
| 02-02-0244 | Outer Diameter 44 mm | Withdrawn |
| 02-04-0212 | Outer Diameter 12 mm | Withdrawn |
| 02-02-0248 | Outer Diameter 48 mm | Withdrawn |
| 02-21-0103 | Outer Diameter 12 mm | Withdrawn |
| 02-04-0112 | Outer Diameter 12 mm | Withdrawn |
| 02-01-0003 | SIZE 3 | Withdrawn |
| 02-02-5448 | Outer Diameter 48 mm | Withdrawn |
| 02-02-2444 | Outer Diameter 44 mm | Withdrawn |
| 02-02-5352 | Width 5 mm | Withdrawn |
| 02-02-0448 | Outer Diameter 48 mm | Withdrawn |
| 02-02-5444 | Outer Diameter 44 mm | Withdrawn |
| 02-04-0352 | Outer Diameter 52 mm | Withdrawn |
| 02-02-5456 | Outer Diameter 56 mm | Withdrawn |
| 02-01-0002 | SIZE 2 | Withdrawn |
| 02-01-0004 | SIZE 4 | Withdrawn |
| 02-04-0210 | Outer Diameter 10 mm | Withdrawn |
| 02-15-0601 | Width 2.5 mm | Withdrawn |
| 02-02-0352 | Outer Diameter 52 mm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K904880 | 1991-01-28 |
| K904879 | 1991-01-28 |
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.