A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a h
| Company | Devices | Share |
|---|---|---|
| Poriferous, Llc | 348 | 47% |
| Stryker Leibinger Gmbh & Co. Kg | 135 | 18% |
| Matrix Surgical Holdings, Llc | 107 | 15% |
| Ceremed, Inc. | 64 | 9% |
| Gyrus Acmi, Llc | 26 | 4% |
| Synthes Gmbh | 25 | 3% |
| Longeviti Neuro Solutions Llc | 17 | 2% |
| Anatomics Pty Ltd | 11 | 1% |
| Medtronic Xomed, Inc. | 2 | 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 |
|---|---|---|
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil | 555 |
| FWP | Prosthesis, Chin, Internal | 210 |
| FWP | PROSTHESIS, CHIN, INTERNAL | 102 |
| FTM | Mesh, surgical | 50 |
| ETA | Replacement, Ossicular Prosthesis, Total | 43 |
| GWO | Plate, cranioplasty, preformed, alterable | 25 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
735 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyethylene craniofacial tissue reconstructive material", from 9 companies. The largest labeler is Poriferous, Llc with 47% of records.
KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil), FWP (Prosthesis, Chin, Internal), FWP (PROSTHESIS, CHIN, INTERNAL), FTM (Mesh, surgical)
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.