TheRay Collared and Collarless Femoral Stem
TheRay femoral stems are titanium alloy implants for cementless hip replacement. Their forged substrate carries a dual coating of plasma-sprayed commercially pure titanium and…
TheRay femoral stems are titanium alloy implants for cementless hip replacement. Their forged substrate carries a dual coating of plasma-sprayed commercially pure titanium and hydroxyapatite. The range includes a collared stem and an otherwise identical collarless version.
The collared stem has a medial collar above the coated region that seats on the resected native calcar. The stems are used within a hip system that also includes femoral heads, acetabular cups and polyethylene liners. Compatible iNSitu bipolar heads provide a separate hemiarthroplasty configuration.
Listed Item
TheRay Collared Femoral Stem, Size 6, Lateralized
Replacement Indications
Total hip use is indicated in skeletally mature patients with a severely painful or disabled joint from specified arthritic, osteonecrotic or dysplastic conditions, acute femoral head or neck fracture, or failed prior hip surgery. Compatible bipolar use includes uncemented primary or revision hemiarthroplasty for specified fractures, osteonecrosis and failed treatment.
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Nextstep Arthropedix, United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K241875 |
| Record published | 2024-12-04 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-81-0002 | In distribution | |
| 12-10-0002 | In distribution | |
| 12-81-0000 | In distribution | |
| 12-81-0009 | In distribution | |
| 12-81-0107 | In distribution | |
| 12-10-0008 | In distribution | |
| 12-11-0006 | In distribution | |
| 12-81-0001 | In distribution | |
| 12-11-0007 | In distribution | |
| 12-11-0002 | In distribution | |
| 12-81-0003 | In distribution | |
| 12-81-0006 | In distribution | |
| 12-81-0008 | In distribution | |
| 12-11-0008 | In distribution | |
| 12-10-0002 | In distribution | |
| 12-81-0101 | In distribution | |
| 12-10-0009 | In distribution | |
| 12-11-0009 | In distribution | |
| 12-81-0100 | In distribution | |
| 12-10-0005 | In distribution | |
| 12-81-0109 | In distribution | |
| 12-81-0108 | In distribution | |
| 12-10-0007 | In distribution | |
| 12-81-0106 | In distribution | |
| 12-11-0005 | In distribution | |
| 12-81-0105 | In distribution | |
| 12-11-0001 | In distribution | |
| 12-10-0006 | In distribution | |
| 12-11-0003 | In distribution | |
| 12-81-0104 | In distribution | |
| 12-11-0000 | In distribution | |
| 12-10-0004 | In distribution | |
| 12-81-0004 | In distribution | |
| 12-10-0000 | In distribution | |
| 12-81-0102 | In distribution | |
| 12-11-0004 | In distribution | |
| 12-81-0103 | In distribution | |
| 12-10-0003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241875 | 2024-09-13 |
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 |
|---|---|---|---|---|---|---|
| Theken Companies, LLC | 510(k) number | 2025-09-11 | Class II | Package design/selection | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. | 409 |
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.