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Device Explorer · FDA GUDID · GMDN 45114

Bone-resection orthopaedic reamer, reusable

An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus,

US‑registered devices5,814in commercial distribution
Companies99labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Smith & Nephew, Inc.1,68529%
Biomet Orthopedics, Llc98817%
Omni Life Science, Inc.2144%
Depuy (Ireland)2144%
Zimmer, Inc.2084%
Tornier, Inc.2084%
Arthrex, Inc.1963%
Exactech, Inc.1362%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.1,68529%
Biomet Orthopedics, Llc98817%
Omni Life Science, Inc.2144%
Depuy (Ireland)2144%
Zimmer, Inc.2084%
Tornier, Inc.2084%
Arthrex, Inc.1963%
Exactech, Inc.1362%
Wright Medical Technology, Inc.1262%
Synthes Gmbh992%
Encore Medical, L.P.902%
Ortho Development Corporation861%

Company = labeler of record on GUDID. 99 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAINSTRUMENTO.I.C. TITANIUMANCHORAGEREUNIONOMEGACarboClear Hybrid Pedicle Screw SystemCarboClear Posterior Cervical Screw SystemCarboClear Pedicle Screw SystemBojinVolition Plating SystemORTHO SOLUTIONS STERILE DRILL BITSMetafix Hip StemUnity Total Knee SystemTriFit TS Blade StemMiniHip Stem

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

FDA product codes

CodeNameDevices
HTOREAMER3,062
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES550
HTOReamer430
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT357
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented193
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce188

GMDN & GCC registration

  • GMDN code 45114 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 85% · 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) · 314Width (Millimeter) · 19Height (Millimeter) · 16Length (Millimeter) · 13Lumen/Inner Diameter (Millimeter) · 9Length (Inch) · 3

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

How many bone-resection orthopaedic reamer, reusable products are registered in the US?

5,814 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone-resection orthopaedic reamer, reusable", from 99 companies. The largest labeler is Smith & Nephew, Inc. with 29% of records.

Which FDA product codes apply?

HTO (REAMER), HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES), HTO (Reamer), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

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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