A non-sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and
| Company | Devices | Share |
|---|---|---|
| Genesys Orthopedics Systems Llc | 136 | 41% |
| Zavation Llc | 68 | 20% |
| Aegis Spine, Inc. | 48 | 14% |
| Orthofix Us Llc | 28 | 8% |
| Tenon Medical, Inc. | 25 | 8% |
| Camber Spine Technologies, Llc | 16 | 5% |
| Pantheon Spinal, Llc | 12 | 4% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| OUR | Sacroiliac Joint Fixation | 354 |
| HWC | Screw, Fixation, Bone | 74 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 16 |
| HTW | BIT, DRILL | 2 |
| FZX | Guide, surgical, instrument | 2 |
| HWR | DRIVER, PROSTHESIS | 1 |
Use these as the dimensions to specify in a tender line.
333 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile", from 7 companies. The largest labeler is Genesys Orthopedics Systems Llc with 41% of records.
OUR (Sacroiliac Joint Fixation), HWC (Screw, Fixation, Bone), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HTW (BIT, DRILL)
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.