A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves
| Company | Devices | Share |
|---|---|---|
| Medacta International Sa | 3,375 | 86% |
| Crossroads Extremity Systems | 221 | 6% |
| Orthosoft Inc | 45 | 1% |
| Zimmer, Inc. | 42 | 1% |
| Genesys Orthopedics Systems Llc | 36 | 1% |
| Depuy Orthopaedics, Inc. | 23 | 1% |
| Spineology Inc. | 21 | 1% |
| Medartis Inc. | 20 | 1% |
| Forma Medical, Inc. | 19 | 0% |
| Depuy (Ireland) | 18 | 0% |
| Smith & Nephew, Inc. | 14 | 0% |
| Pioneer Surgical Technology, Inc. | 14 | 0% |
Company = labeler of record on GUDID. 40 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 | 1,351 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM | 1,316 |
| OOG | Knee Arthroplasty Implantation System | 421 |
| FZX | Guide, Surgical, Instrument | 224 |
| LXH | Orthopedic Manual Surgical Instrument | 217 |
| SBF | Orthopedic Augmented Reality | 215 |
Use these as the dimensions to specify in a tender line.
3,941 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic prosthesis implantation positioning instrument, single-use", from 40 companies. The largest labeler is Medacta International Sa with 86% of records.
JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), OOG (Knee Arthroplasty Implantation System), FZX (Guide, Surgical, Instrument)
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.