Consulting Wallah › Device Explorer › Other devices › Bone-resection orthopaedic reamer, single-use
Device Explorer · FDA GUDID · GMDN 61807

Bone-resection orthopaedic reamer, single-use

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 devices486in commercial distribution
Companies32labelers on GUDID
Single‑use96%of device records
Sterile68%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Arthrex, Inc.10822%
Fusion Orthopedics, Llc469%
Razor Medical Instruments, Inc.378%
Conmed Corporation378%
Crossroads Extremity Systems296%
Paragon 28, Inc.286%
Hpf Srl255%
Biomet Orthopedics, Llc225%

Top labelers

CompanyDevicesShare
Arthrex, Inc.10822%
Fusion Orthopedics, Llc469%
Razor Medical Instruments, Inc.378%
Conmed Corporation378%
Crossroads Extremity Systems296%
Paragon 28, Inc.286%
Hpf Srl255%
Biomet Orthopedics, Llc225%
Trimed, Inc.194%
Osteofit Llc143%
Howmedica Osteonics Corp.133%
Joimax Gmbh122%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TOEPREPREUNIONINSTRUMENTCESSYS®Bone drillTESSYS®Made-To-OrderORTHOLOC 3DiNAX-REAMPhantom Hindfoot TTC/TC Nail SystemPhantom® Fibula Nail SystemAVTRAC MTP Revision SystemArthrex®LEVEL ONELEVEL ONE TRANSBUCCAL

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 INSTRUMENT91
HTOReamer80
HTOREAMER72
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces65
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES60
LXHOrthopedic Manual Surgical Instrument39

GMDN & GCC registration

  • GMDN code 61807 · non‑implantable
  • Single‑use 96% · sterile 68% · Rx‑only 91% · OTC 1%
  • 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) · 40Length (Millimeter) · 4Length (Inch) · 2Outer Diameter (Inch) · 2

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

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

486 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone-resection orthopaedic reamer, single-use", from 32 companies. The largest labeler is Arthrex, Inc. with 22% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HTO (Reamer), HTO (REAMER), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces)

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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