BIO-Modular Shoulder System
40 catalogue numbers from CP550641, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| 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 | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| 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 |
|---|---|---|
| CP550641 | 9 MM 220MM LENGTH | In distribution |
| 113850 | SMALL SIZE 7 MM | In distribution |
| 113886 | 44 mm 22 mm | In distribution |
| 113886 | 44 MM 22 MM | In distribution |
| 113790 | 7MM Ø | In distribution |
| 11-113729 | 13 MM 70 MM | In distribution |
| 113736 | 44mm Head ø 22mm Height | In distribution |
| 113775 | 54MM HEAD Ø 24MM HEIGHT | In distribution |
| 113933 | Medium | In distribution |
| 113874 | LARGE SIZE 4 MM | In distribution |
| 113757 | 40mm Head ø 22mm Height | In distribution |
| 113760 | 40mm Head ø 15mm Height | In distribution |
| 113921 | 44 MM 17 MM | In distribution |
| 113730 | 40MM HEAD Ø 15MM HEIGHT | In distribution |
| 113931 | Small Size 4 mm | In distribution |
| 113870 | SMALL SIZE 4 MM | In distribution |
| 113772 | 54mm Head ø 22mm Height | In distribution |
| 113792 | 9MM Ø | In distribution |
| 113738 | 44mm Head ø 27mm Height | In distribution |
| 113936 | Large | In distribution |
| 113896 | 54 mm 24 mm | In distribution |
| 113944 | LARGE SIZE 10° | In distribution |
| 113730 | 40mm Head ø 15mm Height | In distribution |
| 11-113704 | 8 MM 115 MM | In distribution |
| 11-113720 | 6 MM 70 MM | In distribution |
| 113740 | 48MM HEAD Ø 24MM HEIGHT | In distribution |
| 113774 | 54MM HEAD Ø 27MM HEIGHT | In distribution |
| 11-113804 | 11 MM 190 MM | In distribution |
| 113766 | 44mm Head ø 22mm Height | In distribution |
| CP550457 | 58MM Ø 27MM HEIGHT | In distribution |
| 113926 | 48 MM 27 MM | In distribution |
| 113770 | 48mm Head ø 24mm Height | In distribution |
| CP550145 | 52MM Ø 27MM HEIGHT | In distribution |
| 11-113806 | 13 MM 190 MM | In distribution |
| 113763 | 44mm Head ø 15mm Height | In distribution |
| 113789 | 6MM Ø | In distribution |
| 113888 | 44 mm 27 mm | In distribution |
| 113943 | Medium Size 10° | In distribution |
| 113922 | 44 MM 22 MM | In distribution |
| 113734 | 44MM HEAD Ø 17MM HEIGHT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K010827 | 2001-09-14 |
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.