A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient med
| Company | Devices | Share |
|---|---|---|
| Kls-Martin L.P. | 153 | 47% |
| Materialise Nv | 84 | 26% |
| 3D Systems, Inc. | 44 | 14% |
| Medcad | 17 | 5% |
| 3D Lifeprints Uk Ltd | 6 | 2% |
| Mirrorme3D, Llc | 6 | 2% |
| Limacorporate Spa | 4 | 1% |
| Rtsafe, Inc. | 2 | 1% |
| Onkos Surgical, Inc. | 2 | 1% |
| Axial Medical Printing Limited | 1 | 0% |
| Arthrex, Inc. | 1 | 0% |
| Treace Medical Concepts, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 14 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 |
|---|---|---|
| HWT | TEMPLATE | 155 |
| HWT | Template | 82 |
| LLZ | System, Image Processing, Radiological | 73 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 49 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement | 19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem | 15 |
Use these as the dimensions to specify in a tender line.
323 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", from 14 companies. The largest labeler is Kls-Martin L.P. with 47% of records.
HWT (TEMPLATE), HWT (Template), LLZ (System, Image Processing, Radiological), DZJ (Driver, Wire, And Bone Drill, Manual)
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.