An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it a
| Company | Devices | Share |
|---|---|---|
| Shalby Advanced Technologies, Inc. | 177 | 11% |
| United Orthopedic Corp. | 155 | 10% |
| Zimmer, Inc. | 153 | 10% |
| Corin Ltd | 111 | 7% |
| Howmedica Osteonics Corp. | 108 | 7% |
| Medacta International Sa | 81 | 5% |
| Microport Orthopedics Inc. | 80 | 5% |
| Biomet Orthopedics, Llc | 66 | 4% |
| Exactech, Inc. | 63 | 4% |
| Biopro, Inc. | 60 | 4% |
| Total Joint Orthopedics, Inc. | 53 | 3% |
| Waldemar Link Gmbh & Co. Kg | 52 | 3% |
Company = labeler of record on GUDID. 28 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 |
|---|---|---|
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or | 961 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or | 600 |
| KWL | Prosthesis, hip, hemi-, femoral, metal | 96 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc | 95 |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 78 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 67 |
Use these as the dimensions to specify in a tender line.
1,591 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bipolar femoral head outer component, hemiarthroplasty", from 28 companies. The largest labeler is Shalby Advanced Technologies, Inc. with 11% of records.
KWY (Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or ), KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or ), KWL (Prosthesis, hip, hemi-, femoral, metal), LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc)
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.