Humelock Cemented Shoulder Prosthesis
Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17
8manufacturers in China registered for this device type
21catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Fx Solutions, France |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| 510(k) | K111097 |
| Record published | 2016-12-06 |
| Record revised | 2025-03-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Outer diameter 35 to 54 mm |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 926-1012 | In distribution | |
| 926-1009 | In distribution | |
| 926-1005 | Outer Diameter 41 mm | In distribution |
| 926-1014 | In distribution | |
| 106-4300 | Outer Diameter 43 mm | In distribution |
| 926-1015 | In distribution | |
| 106-4600 | Outer Diameter 46 mm | In distribution |
| 926-1018 | Outer Diameter 48 mm | In distribution |
| 926-1011 | In distribution | |
| 926-1017 | Outer Diameter 41 mm | In distribution |
| 106-4617 | Outer Diameter 46 mm | In distribution |
| 106-3914 | Outer Diameter 39 mm | In distribution |
| 926-1010 | In distribution | |
| 926-1008 | In distribution | |
| 926-1006 | Outer Diameter 48 mm | In distribution |
| 106-4316 | Outer Diameter 43 mm | In distribution |
| 106-3900 | Outer Diameter 39 mm | In distribution |
| 926-1007 | Outer Diameter 54 mm | In distribution |
| 106-5019 | Outer Diameter 50 mm | In distribution |
| 926-1016 | Outer Diameter 35 mm | Withdrawn |
| 926-1004 | Outer Diameter 35 mm | Withdrawn |
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 |
|---|---|
| K130759 | 2013-11-09 |
| K111097 | 2011-11-09 |
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 |
|---|---|---|---|---|---|---|---|
| Fx Shoulder Solutions SAS | 510(k) number | 2018-06-04 | Class II | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 131 units | 2019-04-05 |
| Fx Shoulder Solutions SAS | 510(k) number | 2018-06-04 | Class II | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 145 units | 2019-04-05 |
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.