A sterile implantable device designed to replace the distal tibia (tibial component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated wi
| Company | Devices | Share |
|---|---|---|
| Restor3D, Inc. | 58 | 49% |
| Vilex Llc | 41 | 35% |
| Dt Medtech, Llc | 12 | 10% |
| Zimmer, Inc. | 6 | 5% |
| Stryker Gmbh | 1 | 1% |
Company = labeler of record on GUDID. 5 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 | 128 |
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 47 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 17 |
Use these as the dimensions to specify in a tender line.
118 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated ankle tibia prosthesis", from 5 companies. The largest labeler is Restor3D, Inc. with 49% 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.