A sterile implantable device designed to replace the proximal talus (talar 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 w
| Company | Devices | Share |
|---|---|---|
| Restor3D, Inc. | 35 | 23% |
| Vilex Llc | 24 | 16% |
| Dt Medtech, Llc | 22 | 15% |
| Exactech, Inc. | 20 | 13% |
| Depuy Orthopaedics, Inc. | 18 | 12% |
| Zimmer, Inc. | 12 | 8% |
| Osteomed Llc | 10 | 7% |
| Paragon 28, Inc. | 9 | 6% |
| Stryker Gmbh | 1 | 1% |
Company = labeler of record on GUDID. 9 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 | 79 |
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 60 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 32 |
| HWC | Screw, fixation, bone | 10 |
| QNN | Prosthesis, Total Talus Replacement, Metal | 9 |
| JDB | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED | 6 |
Use these as the dimensions to specify in a tender line.
151 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated ankle talus prosthesis", from 9 companies. The largest labeler is Restor3D, Inc. with 23% of records.
HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), HSN (PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER), NTG (Prosthesis, Ankle, Uncemented, Non-Constrained), HWC (Screw, fixation, bone)
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.