A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a ma
| Company | Devices | Share |
|---|---|---|
| Medacta International Sa | 32 | 64% |
| Biopro, Inc. | 10 | 20% |
| Waldemar Link Gmbh & Co. Kg | 4 | 8% |
| Medisurge Llc | 4 | 8% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, M | 31 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, | 14 |
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M | 5 |
Use these as the dimensions to specify in a tender line.
50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated unicondylar knee femur prosthesis", from 4 companies. The largest labeler is Medacta International Sa with 64% of records.
HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, M), HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, ), HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M)
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.