Consulting Wallah › Device Explorer › Other devices › Sacroiliac joint transarticular fixation/arthrodes
Device Explorer · FDA GUDID · GMDN 58808

Sacroiliac joint transarticular fixation/arthrodesis implant, coated

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 metal [e.g., titanium (Ti)] with a porous plasma spr

US‑registered devices856in commercial distribution
Companies7labelers on GUDID
Single‑use97%of device records
Sterile91%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medacta International Sa33940%
Si-Bone Inc.24328%
Paradigm Spine Gmbh12314%
Xtant Medical Holdings, Inc.607%
L&K Biomed Co. ,Ltd.607%
Sail Fusion, Llc283%
Aurora Spine, Inc.30%

Top labelers

CompanyDevicesShare
Medacta International Sa33940%
Si-Bone Inc.24328%
Paradigm Spine Gmbh12314%
Xtant Medical Holdings, Inc.607%
L&K Biomed Co. ,Ltd.607%
Sail Fusion, Llc283%
Aurora Spine, Inc.30%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SImmetry Washer, 14.5mm ImplantSImmetry Washer, 12.5mm ImplantSImmetry Washer, 10.5mm ImplantSImmetry Washer, 8.5mm ImplantSImmetry LAG Implant, 14.5mm x 110mmSImmetry LAG Implant, 14.5mm x 105mmSImmetry LAG Implant, 14.5mm x 100mmSImmetry LAG Implant, 14.5mm x 95mmSImmetry LAG Implant, 14.5mm x 90mmSImmetry LAG Implant, 14.5mm x 85mmSImmetry LAG Implant, 14.5mm x 80mmSImmetry LAG Implant, 14.5mm x 75mmSImmetry LAG Implant, 14.5mm x 70mmSImmetry LAG Implant, 14.5mm x 65mmSImmetry LAG Implant, 14.5mm x 60mmSImmetry LAG Implant, 14.5mm x 55mm

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 Fixation724
HWCScrew, Fixation, Bone228
HTNWasher, Bolt Nut207
OURSacroiliac joint fixation199
NKBThoracolumbosacral Pedicle Screw System8
FZXGuide, surgical, instrument2

GMDN & GCC registration

  • GMDN code 58808 · implantable
  • Single‑use 97% · sterile 91% · Rx‑only 93% · 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) · 274Outer Diameter (Millimeter) · 264Width (Millimeter) · 13

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

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

856 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, coated", from 7 companies. The largest labeler is Medacta International Sa with 40% of records.

Which FDA product codes apply?

OUR (Sacroiliac Joint Fixation), HWC (Screw, Fixation, Bone), HTN (Washer, Bolt Nut), OUR (Sacroiliac joint fixation)

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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