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Device Explorer · FDA GUDID · GMDN 32854

Orthopaedic bone pin, non-bioabsorbable

A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, a

US‑registered devices5,320in commercial distribution
Companies119labelers on GUDID
Single‑use89%of device records
Sterile28%labelled sterile
Prescription86%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Stryker Gmbh4428%
Zavation Llc3306%
Smith & Nephew, Inc.3096%
Biomet Orthopedics, Llc2996%
Zimmer, Inc.2354%
Teleflex Incorporated2214%
Orthopediatrics Corp.2144%
Synthes Gmbh2024%

Top labelers

CompanyDevicesShare
Stryker Gmbh4428%
Zavation Llc3306%
Smith & Nephew, Inc.3096%
Biomet Orthopedics, Llc2996%
Zimmer, Inc.2354%
Teleflex Incorporated2214%
Orthopediatrics Corp.2144%
Synthes Gmbh2024%
Hnm Stainless, Llc.2004%
Microaire Surgical Instruments Llc1994%
Gebr. Brasseler Gmbh & Co. Kg1783%
Key Surgical, Inc.1723%

Company = labeler of record on GUDID. 119 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HOFFMANN LRFNAVARIAXMINITOETACINSTRUMENTEASYSTEPProCinchAPEXAXSOSOMEGASTEINMANNHOFFMANNSMART TOEANCHORAGEVariAx

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, SMOOTH1,236
HTYPin, Fixation, Smooth1,157
JDWPIN, FIXATION, THREADED969
HWCScrew, fixation, bone513
NKBThoracolumbosacral Pedicle Screw System308
HRSPlate, fixation, bone248

GMDN & GCC registration

  • GMDN code 32854 · implantable
  • Single‑use 89% · sterile 28% · Rx‑only 86% · 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) · 1,013Outer Diameter (Millimeter) · 518Length (Inch) · 350Width (Millimeter) · 283Length (Centimeter) · 109Depth (Millimeter) · 22

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

How many orthopaedic bone pin, non-bioabsorbable products are registered in the US?

5,320 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone pin, non-bioabsorbable", from 119 companies. The largest labeler is Stryker Gmbh with 8% of records.

Which FDA product codes apply?

HTY (PIN, FIXATION, SMOOTH), HTY (Pin, Fixation, Smooth), JDW (PIN, FIXATION, THREADED), 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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