An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactur
| Company | Devices | Share |
|---|---|---|
| Oxford Performance Materials, Inc. | 4,813 | 90% |
| Kls-Martin L.P. | 261 | 5% |
| Synthes Gmbh | 251 | 5% |
| Materialise Nv | 6 | 0% |
| Finceramica Faenza Spa | 1 | 0% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 4,647 |
| GXN | PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE | 380 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil | 211 |
| JEY | PLATE, BONE | 103 |
| DZJ | DRIVER, WIRE, AND BONE DRILL, MANUAL | 96 |
| GXP | METHYL METHACRYLATE FOR CRANIOPLASTY | 93 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
5,332 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made cranial bone prosthesis", from 5 companies. The largest labeler is Oxford Performance Materials, Inc. with 90% of records.
GXN (Plate, Cranioplasty, Preformed, Non-Alterable), GXN (PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE), KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil), JEY (PLATE, BONE)
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.