Consulting Wallah › Device Explorer › Other devices › Orthopaedic guidewire, single-use
Device Explorer · FDA GUDID · GMDN 62729

Orthopaedic guidewire, single-use

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 devices675in commercial distribution
Companies48labelers on GUDID
Single‑use91%of device records
Sterile28%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Orthopediatrics Corp.18928%
Tyber Medical, Llc6710%
Synthes Gmbh649%
Orthopediatrics Canada Ulc629%
Fusion Orthopedics, Llc315%
Smith & Nephew, Inc.264%
Paragon 28, Inc.213%
Osteocentric Technologies, Inc.193%

Top labelers

CompanyDevicesShare
Orthopediatrics Corp.18928%
Tyber Medical, Llc6710%
Synthes Gmbh649%
Orthopediatrics Canada Ulc629%
Fusion Orthopedics, Llc315%
Smith & Nephew, Inc.264%
Paragon 28, Inc.213%
Osteocentric Technologies, Inc.193%
Acumed Llc173%
Forma Medical, Inc.152%
Vilex Llc142%
Orthopedic Designs North America, Inc.142%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAASNISGIRO GROWTH MODULATION SYSTEMHINGE PEDIATRIC PLATING SYSTEMFASSIER-DUVAL TELESCOPIC IM SYSTEMSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMThe Locking Pediatric Osteotomy Plate (LolliPOP)GAP ENDO-EXO MEDULLARY SYSTEMFREE GLIDING SCFE SCREW SYSTEMExchange K-Wire Ø2.4mm x 450mm - Blunt TipK-Wire Ø2.4mm x 280mm - Blunt TipK-Wire Ø2.4mm x 280mm - Trocar TipPiccolo Composite Nailing SystemCarboClear Pedicle Screw SystemGuide WiresInion CompressOn™ Instrument

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 INSTRUMENT128
LXHOrthopedic manual surgical instrument84
KIJInstrument, surgical, orthopedic, dc-powered motor and acces84
HRSPlate, fixation, bone78
HWCScrew, fixation, bone61
LXHOrthopedic Manual Surgical Instrument47

GMDN & GCC registration

  • GMDN code 62729 · non‑implantable
  • Single‑use 91% · sterile 28% · Rx‑only 97% · 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) · 128Outer Diameter (Millimeter) · 119Guidewire Diameter (Millimeter) · 16Length (Inch) · 15Guidewire Length (Millimeter) · 12Outer Diameter (Inch) · 2

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

How many orthopaedic guidewire, single-use products are registered in the US?

675 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic guidewire, single-use", from 48 companies. The largest labeler is Orthopediatrics Corp. with 28% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), KIJ (Instrument, surgical, orthopedic, dc-powered motor and acces), 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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