A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti
| Company | Devices | Share |
|---|---|---|
| Skeletal Dynamics L.L.C. | 95 | 15% |
| Stryker Gmbh | 61 | 10% |
| Arthrex, Inc. | 58 | 9% |
| Tornier, Inc. | 52 | 8% |
| Wright Medical Technology, Inc. | 51 | 8% |
| Zimmer, Inc. | 48 | 8% |
| Synthes Gmbh | 40 | 6% |
| In2Bones Usa, Llc | 32 | 5% |
| Biomet Orthopedics, Llc | 31 | 5% |
| Biopoly, Llc | 30 | 5% |
| Kapp Surgical Instrument Co. | 29 | 5% |
| Tornier | 23 | 4% |
Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER | 542 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 126 |
| JDB | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED | 100 |
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED | 53 |
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 10 |
Use these as the dimensions to specify in a tender line.
616 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Elbow radius prosthesis", from 16 companies. The largest labeler is Skeletal Dynamics L.L.C. with 15% of records.
KWI (PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER), KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), JDB (PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED), JDC (PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.