Consulting Wallah › Device Explorer › Other devices › Orthopaedic broach
Device Explorer · FDA GUDID · GMDN 36167

Orthopaedic broach

A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

US‑registered devices4,095in commercial distribution
Companies63labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Smith & Nephew, Inc.58314%
Howmedica Osteonics Corp.3088%
Exactech, Inc.2817%
Waldemar Link Gmbh & Co. Kg2566%
Ortho Development Corporation2526%
United Orthopedic Corp.2396%
Signature Orthopaedics Pty Ltd2105%
Depuy (Ireland)2075%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.58314%
Howmedica Osteonics Corp.3088%
Exactech, Inc.2817%
Waldemar Link Gmbh & Co. Kg2566%
Ortho Development Corporation2526%
United Orthopedic Corp.2396%
Signature Orthopaedics Pty Ltd2105%
Depuy (Ireland)2075%
Biomet Orthopedics, Llc1594%
Nextstep Arthropedix, Llc1153%
Limacorporate Spa1123%
Medtronic Sofamor Danek, Inc.1012%

Company = labeler of record on GUDID. 63 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AInstrumentREUNIONINSTRUMENTOSSIO® Punch PackCorin TriFit CF Hip StemCorin Metafix Hip StemUnity Total Knee SystemTaperFit Cemented Hip SystemMiniHip StemMetafix Hip StemMetafix HIp StemTriFit TS Blade StemCorin Taper-Fit Total Hip SystemU2 Total Knee SystemConformity Stem

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

FDA product codes

CodeNameDevices
HTQBROACH1,014
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT527
HTQBroach449
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce412
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented345
JDGProsthesis, hip, femoral component, cemented, metal334

GMDN & GCC registration

  • GMDN code 36167 · non‑implantable
  • Single‑use 1% · sterile 0% · 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

Outer Diameter (Millimeter) · 151Length (Millimeter) · 142Height (Millimeter) · 54Width (Millimeter) · 48

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

How many orthopaedic broach products are registered in the US?

4,095 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic broach", from 63 companies. The largest labeler is Smith & Nephew, Inc. with 14% of records.

Which FDA product codes apply?

HTQ (BROACH), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HTQ (Broach), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce)

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.

How do I get quotes?

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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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