A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.
| Company | Devices | Share |
|---|---|---|
| Restor3D, Inc. | 127 | 41% |
| Vilex Llc | 112 | 36% |
| Depuy Orthopaedics, Inc. | 35 | 11% |
| Dt Medtech, Llc | 24 | 8% |
| Trilliant Surgical, Llc | 10 | 3% |
| Stryker Gmbh | 3 | 1% |
Company = labeler of record on GUDID. 6 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 | 271 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 271 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 43 |
Use these as the dimensions to specify in a tender line.
311 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ankle prosthesis bearing", from 6 companies. The largest labeler is Restor3D, Inc. with 41% of records.
HSN (PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER), HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), NTG (Prosthesis, Ankle, Uncemented, Non-Constrained)
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.