Consulting Wallah › Device Explorer › Other devices › Sacroiliac joint transarticular fixation/arthrodes
Device Explorer · FDA GUDID · GMDN 61485

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

An 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 typically

US‑registered devices1,374in commercial distribution
Companies27labelers on GUDID
Single‑use95%of device records
Sterile34%labelled sterile
Prescription81%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tenon Medical, Inc.22116%
L&K Biomed Co. ,Ltd.13210%
Cutting Edge Spine, Llc1299%
Spinefrontier, Inc.1199%
Aegis Spine, Inc.1017%
Osteocentric Technologies, Inc.967%
Nexxt Spine, Llc745%
Genesys Orthopedics Systems Llc705%

Top labelers

CompanyDevicesShare
Tenon Medical, Inc.22116%
L&K Biomed Co. ,Ltd.13210%
Cutting Edge Spine, Llc1299%
Spinefrontier, Inc.1199%
Aegis Spine, Inc.1017%
Osteocentric Technologies, Inc.967%
Nexxt Spine, Llc745%
Genesys Orthopedics Systems Llc705%
Curiteva, Inc.604%
Osseus Fusion Systems, Llc574%
Xenix Medical Llc363%
Choice Spine, Lp332%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ø13mm Sacroiliac Falco Fusion Screw - L75mmØ13mm Sacroiliac Falco Fusion Screw - L70mmØ13mm Sacroiliac Falco Fusion Screw - L65mmØ13mm Sacroiliac Falco Fusion Screw - L60mmØ13mm Sacroiliac Falco Fusion Screw - L55mmØ13mm Sacroiliac Falco Fusion Screw - L50mmØ13mm Sacroiliac Falco Fusion Screw - L45mmØ13mm Sacroiliac Falco Fusion Screw - L40mmØ13mm Sacroiliac Falco Fusion Screw - L35mmØ11mm Sacroiliac Falco Fusion Screw - L75mmØ11mm Sacroiliac Falco Fusion Screw - L70mmØ11mm Sacroiliac Falco Fusion Screw - L65mmØ11mm Sacroiliac Falco Fusion Screw - L60mmØ11mm Sacroiliac Falco Fusion Screw - L55mmØ11mm Sacroiliac Falco Fusion Screw - L50mmØ11mm Sacroiliac Falco Fusion Screw - L45mm

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OURSacroiliac Joint Fixation1,239
OURSacroiliac joint fixation173
HWCScrew, Fixation, Bone146
OLOOrthopedic Stereotaxic Instrument86
NKBThoracolumbosacral Pedicle Screw System50
LXHOrthopedic manual surgical instrument33

GMDN & GCC registration

  • GMDN code 61485 · implantable
  • Single‑use 95% · sterile 34% · Rx‑only 81% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 544Outer Diameter (Millimeter) · 515Width (Millimeter) · 29Height (Millimeter) · 20Outer Diameter (Nanometer) · 1

Use these as the dimensions to specify in a tender line.

How many sacroiliac joint transarticular fixation/arthrodesis implant, uncoated products are registered in the US?

1,374 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", from 27 companies. The largest labeler is Tenon Medical, Inc. with 16% of records.

Which FDA product codes apply?

OUR (Sacroiliac Joint Fixation), OUR (Sacroiliac joint fixation), HWC (Screw, Fixation, Bone), OLO (Orthopedic Stereotaxic Instrument)

Is this the same as UAE/GCC registration?

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.

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