A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of
| Company | Devices | Share |
|---|---|---|
| Wright Medical Technology, Inc. | 623 | 26% |
| Paragon 28, Inc. | 574 | 24% |
| Smith & Nephew, Inc. | 389 | 16% |
| Ascension Orthopedics, Inc. | 388 | 16% |
| Exactech, Inc. | 259 | 11% |
| In2Bones | 156 | 6% |
| Restor3D, Inc. | 34 | 1% |
| Zimmer, Inc. | 18 | 1% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2,213 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 260 |
Use these as the dimensions to specify in a tender line.
2,441 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fixed-bearing total ankle prosthesis", from 8 companies. The largest labeler is Wright Medical Technology, Inc. with 26% of records.
HSN (PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER), HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
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.