A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system
| Company | Devices | Share |
|---|---|---|
| Restor3D, Inc. | 893 | 68% |
| 4Web Medical | 169 | 13% |
| Tyber Medical, Llc | 54 | 4% |
| Wright Medical Technology, Inc. | 53 | 4% |
| Auxano Medical Llc | 45 | 3% |
| Additive Orthopaedics Llc | 45 | 3% |
| Sintx Technologies, Inc. | 27 | 2% |
| Ames Medical Prosthetic Solutions S.A. | 18 | 1% |
| Paragon 28, Inc. | 12 | 1% |
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 |
|---|---|---|
| SAI | Ankle Fusion Cage | 824 |
| PLF | Bone Wedge | 252 |
| HRS | Plate, Fixation, Bone | 187 |
| HWC | Screw, fixation, bone | 84 |
| HRS | Plate, fixation, bone | 74 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 69 |
Use these as the dimensions to specify in a tender line.
1,316 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metallic osteotomy fusion cage, non-customized ", from 9 companies. The largest labeler is Restor3D, Inc. with 68% of records.
SAI (Ankle Fusion Cage), PLF (Bone Wedge), HRS (Plate, Fixation, Bone), HWC (Screw, fixation, 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.