Consulting Wallah › Device Explorer › Wound care & sutures › Orthopaedic fixation suture button
Device Explorer · FDA GUDID · GMDN 65038

Orthopaedic fixation suture button

A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone p

US‑registered devices102in commercial distribution
Companies9labelers on GUDID
Single‑use96%of device records
Sterile95%labelled sterile
Prescription91%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Arthrex, Inc.6160%
Dunamis Medical, Llc2625%
T.A.G Medical Products Agricultural Cooperative Association55%
Conmed Corporation44%
Wright Medical Technology, Inc.22%
Vilex Llc11%
Skeletal Dynamics L.L.C.11%
In2Bones Usa, Llc11%

Top labelers

CompanyDevicesShare
Arthrex, Inc.6160%
Dunamis Medical, Llc2625%
T.A.G Medical Products Agricultural Cooperative Association55%
Conmed Corporation44%
Wright Medical Technology, Inc.22%
Vilex Llc11%
Skeletal Dynamics L.L.C.11%
In2Bones Usa, Llc11%
Orthopaedic Implant Company, The11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SynchfixGRAVITY SYNCHFIXArthrex®Micro Orca™Micro Constrictor ®Enofix ™ with Constrictor® Technology SyndesmotiConstrictor® Mini SnareOrca™ Knotless Tendon RepairConstrictor® Syndesmosis Repair KitConstrictor® RopeConstrictor® Mini Syndesmosis Repair KitConstrictor® Mini for Syndesmosis RepairSyndex with Constrictor® TechnologyConstrictor - Syndesmosis Knotless Adjustable BuOlecranon Transporter™ Repair KitConstrictor® 2.0 Syndesmosis Repair Kit

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

FDA product codes

CodeNameDevices
HTNWASHER, BOLT NUT43
MBIFastener, Fixation, Nondegradable, Soft Tissue32
HTNWasher, Bolt Nut30
HRSPLATE, FIXATION, BONE15
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE13
GAPSUTURE, NONABSORBABLE, SILK11

GMDN & GCC registration

  • GMDN code 65038 · implantable
  • Single‑use 96% · sterile 95% · Rx‑only 91% · 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) · 1

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

No closely related category with 50+ devices.

How many orthopaedic fixation suture button products are registered in the US?

102 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic fixation suture button", from 9 companies. The largest labeler is Arthrex, Inc. with 60% of records.

Which FDA product codes apply?

HTN (WASHER, BOLT NUT), MBI (Fastener, Fixation, Nondegradable, Soft Tissue), HTN (Washer, Bolt Nut), HRS (PLATE, FIXATION, BONE)

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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