ReUnion
Humeral Component - Long Stem
8manufacturers in China registered for this device type
23catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
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 | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K001419 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R5351-4608 | Distal Diameter: 8.0 Millimeter | In distribution |
| R5351-4515 | Distal Diameter: 15.0 Millimeter | In distribution |
| R5352-4518 | Diameter: 45.0 Millimeter | In distribution |
| R5350-4521 | Thickness: 21.0 Millimeter | In distribution |
| R5351-4509 | Distal Diameter: 9.0 Millimeter | In distribution |
| R5350-5021 | Diameter: 50.0 Millimeter | In distribution |
| R5351-4612 | Distal Diameter: 12.0 Millimeter | In distribution |
| R5350-4018 | Thickness: 18.0 Millimeter | In distribution |
| R5352-5021 | Diameter: 50.0 Millimeter | In distribution |
| R5351-4508 | Distal Diameter: 8.0 Millimeter | In distribution |
| R5351-4510 | Distal Diameter: 10.0 Millimeter | In distribution |
| R5350-5524 | Thickness: 24.0 Millimeter | In distribution |
| R5350-5518 | Diameter: 55.0 Millimeter | In distribution |
| R5351-4507 | Distal Diameter: 7.0 Millimeter | In distribution |
| R5350-5028 | Thickness: 28.0 Millimeter | In distribution |
| R5351-4610 | Distal Diameter: 10.0 Millimeter | In distribution |
| R5350-4524 | Thickness: 24.0 Millimeter | In distribution |
| R5352-4018 | Thickness: 18.0 Millimeter | In distribution |
| R5350-4515 | Thickness: 15.0 Millimeter | In distribution |
| R5351-4511 | Distal Diameter: 11.0 Millimeter | In distribution |
| R5351-4512 | Distal Diameter: 12.0 Millimeter | In distribution |
| R5351-4513 | Distal Diameter: 13.0 Millimeter | In distribution |
| R5351-4514 | Distal Diameter: 14.0 Millimeter | 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 |
|---|---|
| K070963 | 2007-05-04 |
| K062845 | 2006-12-13 |
| K061677 | 2006-07-10 |
| K040128 | 2004-03-26 |
| K032264 | 2003-08-08 |
| K001419 | 2000-07-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
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.