A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Componen
| Company | Devices | Share |
|---|---|---|
| Unik Orthopedics Inc. | 568 | 75% |
| Conformis, Inc. | 132 | 17% |
| Think Surgical, Inc. | 22 | 3% |
| Restor3D, Inc. | 18 | 2% |
| Smith & Nephew, Inc. | 11 | 1% |
| Avid Medical, Inc. | 9 | 1% |
| Zimmer, Inc. | 1 | 0% |
| Depuy (Ireland) | 1 | 0% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| OOG | Knee Arthroplasty Implantation System | 700 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 694 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un | 576 |
| LLZ | System, Image Processing, Radiological | 230 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 63 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM | 51 |
Use these as the dimensions to specify in a tender line.
762 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total knee prosthesis implantation guide-instrument kit", from 8 companies. The largest labeler is Unik Orthopedics Inc. with 75% of records.
OOG (Knee Arthroplasty Implantation System), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un), LLZ (System, Image Processing, Radiological)
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.