A prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic
| Company | Devices | Share |
|---|---|---|
| Signature Orthopaedics Pty Ltd | 300 | 100% |
Company = labeler of record on GUDID. 1 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 |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 300 |
Use these as the dimensions to specify in a tender line.
300 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Temporary knee prosthesis, non-customized", from 1 companies. The largest labeler is Signature Orthopaedics Pty Ltd with 100% of records.
JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem)
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.