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Device Explorer · FDA GUDID · GMDN 45109

Orthopaedic reamer guide

An orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joi

US‑registered devices679in commercial distribution
Companies34labelers on GUDID
Single‑use3%of device records
Sterile2%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Limacorporate Spa11918%
Smith & Nephew, Inc.619%
Biomet Orthopedics, Llc619%
Waldemar Link Gmbh & Co. Kg507%
Arthrex, Inc.497%
United Orthopedic Corp.467%
Depuy (Ireland)396%
Zimmer, Inc.264%

Top labelers

CompanyDevicesShare
Limacorporate Spa11918%
Smith & Nephew, Inc.619%
Biomet Orthopedics, Llc619%
Waldemar Link Gmbh & Co. Kg507%
Arthrex, Inc.497%
United Orthopedic Corp.467%
Depuy (Ireland)396%
Zimmer, Inc.264%
Exactech, Inc.264%
Implantcast Gmbh254%
Ortho Development Corporation254%
Depuy Orthopaedics, Inc.223%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTU2 Total Knee SystemU-Wise Hip Surgical Guide TemplateU2™ KneeUKNEE™U2™ HipUSTAR II Knee SystemACS® Uni Reamer guideACS®EcoFit® broach handle with double offset rightEcoFit® broach handle with double offset leftLINK Instruments - Alignment and positioning insLINK Instruments - Saw and drill guidesEndo-Model Knee System - InstrumentsGemini SL Total Knee System - InstrumentsLinkSymphoKnee - Instruments

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 INSTRUMENT101
LXHOrthopedic Manual Surgical Instrument89
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement83
PHXShoulder Prosthesis, Reverse Configuration76
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente62
FZXGuide, surgical, instrument56

GMDN & GCC registration

  • GMDN code 45109 · non‑implantable
  • Single‑use 3% · sterile 2% · Rx‑only 83% · 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

Outer Diameter (Millimeter) · 41Length (Millimeter) · 16Width (Millimeter) · 13Angle (degree) · 13Depth (Millimeter) · 9Height (Millimeter) · 9

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

How many orthopaedic reamer guide products are registered in the US?

679 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic reamer guide", from 34 companies. The largest labeler is Limacorporate Spa with 18% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement), PHX (Shoulder Prosthesis, Reverse Configuration)

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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