An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/o
| Company | Devices | Share |
|---|---|---|
| Ascension Orthopedics, Inc. | 22 | 26% |
| Smith & Nephew, Inc. | 17 | 20% |
| Fusion Orthopedics, Llc | 16 | 19% |
| Brm Extremities Srl | 16 | 19% |
| Wright Medical Technology, Inc. | 8 | 9% |
| In2Bones Usa, Llc | 7 | 8% |
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 |
|---|---|---|
| KWH | PROSTHESIS, TOE, CONSTRAINED, POLYMER | 53 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 39 |
| KWD | PROSTHESIS, TOE, HEMI-, PHALANGEAL | 14 |
| PNW | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement | 4 |
Use these as the dimensions to specify in a tender line.
86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total metatarsophalangeal joint prosthesis, one-piece", from 6 companies. The largest labeler is Ascension Orthopedics, Inc. with 26% of records.
KWH (PROSTHESIS, TOE, CONSTRAINED, POLYMER), KWH (Prosthesis, Toe, Constrained, Polymer), KWD (PROSTHESIS, TOE, HEMI-, PHALANGEAL), PNW (Prosthesis, Metatarsophalangeal Joint Cartilage Replacement )
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.