Consulting Wallah › Device Explorer › Other devices › Orthopaedic bone wire
Device Explorer · FDA GUDID · GMDN 35685

Orthopaedic bone wire

A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight conf

US‑registered devices2,079in commercial distribution
Companies72labelers on GUDID
Single‑use91%of device records
Sterile23%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Gsource Llc29614%
Mahe Medical Gmbh29414%
Biomet Orthopedics, Llc28314%
Simpex Medical, Inc.1035%
Spinal Elements, Inc.1025%
Medartis Ag874%
De Soutter Medical Limited844%
Wright Medical Technology, Inc.693%

Top labelers

CompanyDevicesShare
Gsource Llc29614%
Mahe Medical Gmbh29414%
Biomet Orthopedics, Llc28314%
Simpex Medical, Inc.1035%
Spinal Elements, Inc.1025%
Medartis Ag874%
De Soutter Medical Limited844%
Wright Medical Technology, Inc.693%
Vilex In Tennessee, Inc.693%
Ortho Solutions Holdings Limited643%
Biopro, Inc.613%
Merete Gmbh533%

Company = labeler of record on GUDID. 72 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dall-MilesHBS-Guide Wire ø 1.0x80mmSteinmann pin 3 Shank End, Diamond Point 2.4mm/2Steinmann pin w. trocar/round end threadedSteinmann pin w. double end trocarpoint threadedSteinmann pin w. lanzet/round end 4.0mm/229mm, 6Steinmann pin w. lanzet/round end 3.2mm/229mm, 6Steinmann pin w. lanzet/round end 2.8mm/229mm, 6Steinmann pin w. lanzet/round end 2.4mm/229mm, 6Steinmann pin w. double end lanzet point 2.8mm/2Steinmann pin w. double end lanzet point 2.4mm/2Steinmann pin w. double end lanzet point 2.0mm/2Steinmann pin w. trocar/round end 4.5mm/229mm, 6Steinmann pin w. trocar/round end 4.0mm/229mm, 6Steinmann pin w. trocar/round end 3.5mm/229mm, 6Steinmann pin w. trocar/round end 3.2mm/229mm, 6

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

FDA product codes

CodeNameDevices
HTYPIN, FIXATION, SMOOTH610
HTYPin, Fixation, Smooth500
LXHOrthopedic Manual Surgical Instrument201
HWCScrew, Fixation, Bone130
HXIPasser, Wire, Orthopedic100
JDWPin, Fixation, Threaded94

GMDN & GCC registration

  • GMDN code 35685 · non‑implantable
  • Single‑use 91% · sterile 23% · Rx‑only 87% · 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) · 423Outer Diameter (Millimeter) · 414Width (Millimeter) · 29Length (Centimeter) · 13Length (Meter) · 10Guidewire Diameter (Millimeter) · 3

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

How many orthopaedic bone wire products are registered in the US?

2,079 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone wire", from 72 companies. The largest labeler is Gsource Llc with 14% of records.

Which FDA product codes apply?

HTY (PIN, FIXATION, SMOOTH), HTY (Pin, Fixation, Smooth), LXH (Orthopedic Manual Surgical Instrument), HWC (Screw, 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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