A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatom
| Company | Devices | Share |
|---|---|---|
| Kls-Martin L.P. | 149 | 46% |
| Materialise Nv | 107 | 33% |
| Medcad | 54 | 17% |
| Materialise Usa, L.L.C. | 6 | 2% |
| Biomet Orthopedics, Llc | 3 | 1% |
| Guidedsmile Llc | 2 | 1% |
| Dentsply Ih, Inc. | 1 | 0% |
| Restor3D, Inc. | 1 | 0% |
| Ziyang Rayform Technology Co., Ltd. | 1 | 0% |
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 |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 153 |
| OOG | Knee Arthroplasty Implantation System | 149 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un | 134 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 122 |
| LLZ | System, image processing, radiological | 122 |
| DZJ | DRIVER, WIRE, AND BONE DRILL, MANUAL | 101 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
324 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made organ/bone anatomy model/surgical guide kit", from 9 companies. The largest labeler is Kls-Martin L.P. with 46% of records.
JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), OOG (Knee Arthroplasty Implantation System), MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un), OIY (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.