A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation o
| Company | Devices | Share |
|---|---|---|
| Microport Orthopedics Inc. | 3,700 | 91% |
| 3D Systems, Inc. | 85 | 2% |
| Materialise Nv | 63 | 2% |
| Smith & Nephew, Inc. | 52 | 1% |
| Fusion Orthopedics, Llc | 30 | 1% |
| Ascension Orthopedics, Inc. | 28 | 1% |
| Biopro, Inc. | 24 | 1% |
| Treace Medical Concepts, Inc. | 19 | 0% |
| Catalyst Orthoscience Inc. | 9 | 0% |
| Optimized Ortho Pty Ltd | 8 | 0% |
| Limacorporate Spa | 8 | 0% |
| 3D-Side | 7 | 0% |
Company = labeler of record on GUDID. 29 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 | 4,885 |
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN | 4,852 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 104 |
| LLZ | System, Image Processing, Radiological | 79 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 76 |
| OOG | Knee Arthroplasty Implantation System | 53 |
Use these as the dimensions to specify in a tender line.
4,088 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made orthopaedic/craniofacial surgical guide", from 29 companies. The largest labeler is Microport Orthopedics Inc. with 91% of records.
JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), PBF (Orthopaedic Surgical Planning And Instrument Guides), 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.
Add custom-made orthopaedic/craniofacial surgical guide to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.