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Device Explorer · FDA GUDID · GMDN 46165

Orthopaedic guidewire, reusable

A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It

US‑registered devices1,044in commercial distribution
Companies55labelers on GUDID
Single‑use30%of device records
Sterile13%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc10810%
Synthes Gmbh929%
T.A.G Medical Products Agricultural Cooperative Association899%
Medos International Sàrl717%
Orthofix Srl666%
Stryker Gmbh646%
I.T.S. Gmbh545%
Smith & Nephew, Inc.454%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc10810%
Synthes Gmbh929%
T.A.G Medical Products Agricultural Cooperative Association899%
Medos International Sàrl717%
Orthofix Srl666%
Stryker Gmbh646%
I.T.S. Gmbh545%
Smith & Nephew, Inc.454%
Cg Medtech Co.,Ltd.454%
S.B.M434%
Fusion Orthopedics, Llc363%
Ascension Orthopedics, Inc.343%

Company = labeler of record on GUDID. 55 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAGAMMAASNIST2 ALPHANAFIXOSOMEGAGuide Wire, with threaded tip, φ3.2, 320mmGuide Wire, with olive head, φ2.5, length 1000mmGuide Wire Φ2.5, length 250mmGuide Wire Φ2.5, length 660mm, without olive heaGuide Wire Φ2.5, length 660mm, with olive headGuide Wire φ2.5*250 with Threaded TipMultiple Wire Guide, for φ2.5 Guide WireParallel Wire Guide, for φ2.5 Guide Wire, AdjustGuide Wire φ1.1*150mm

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

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument230
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT174
FZXGuide, surgical, instrument114
HXIPASSER, WIRE, ORTHOPEDIC73
HSBRod, Fixation, Intramedullary And Accessories66
LXHOrthopedic manual surgical instrument59

GMDN & GCC registration

  • GMDN code 46165 · non‑implantable
  • Single‑use 30% · sterile 13% · Rx‑only 80% · 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) · 186Outer Diameter (Millimeter) · 92Width (Millimeter) · 22Height (Millimeter) · 7Length (Inch) · 1Angle (degree) · 1

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

How many orthopaedic guidewire, reusable products are registered in the US?

1,044 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic guidewire, reusable", from 55 companies. The largest labeler is Biomet Orthopedics, Llc with 10% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, surgical, instrument), HXI (PASSER, WIRE, ORTHOPEDIC)

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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