Consulting Wallah › Device Explorer › Other devices › Medullary canal orthopaedic reamer, flexible
Device Explorer · FDA GUDID · GMDN 35297

Medullary canal orthopaedic reamer, flexible

An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylin

US‑registered devices1,032in commercial distribution
Companies31labelers on GUDID
Single‑use8%of device records
Sterile6%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc17817%
Mps Micro Precision Systems Ag14514%
Signature Orthopaedics Pty Ltd11311%
Avalign Technologies, Inc.727%
Synthes Gmbh586%
Arthrex, Inc.495%
United Orthopedic Corp.485%
Advanced Orthopaedic Solutions, Inc.454%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc17817%
Mps Micro Precision Systems Ag14514%
Signature Orthopaedics Pty Ltd11311%
Avalign Technologies, Inc.727%
Synthes Gmbh586%
Arthrex, Inc.495%
United Orthopedic Corp.485%
Advanced Orthopaedic Solutions, Inc.454%
Stryker Gmbh404%
Cg Medtech Co.,Ltd.394%
Stryker Corporation263%
Orthopaedic Implant Company, The263%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIXCUTApexOXFORD ANKLE FUSION NAIL(AFN) SYSTEMResolve Modular Revision StemU2 Total Knee SystemU2™ HipU2 Hip StemNAMUTARS® medullary cavity reamer ic connectionAESCULAPLINK Instruments - Drills, reamers and saw bladeTRIGENPhantom Hindfoot TTC/TC Nail SystemN/AVanguard® SSK 360 InstrumentTM Reverse Shoulder system

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

FDA product codes

CodeNameDevices
HTOReamer314
HTOREAMER269
LXHOrthopedic Manual Surgical Instrument171
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented84
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 84
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce84

GMDN & GCC registration

  • GMDN code 35297 · non‑implantable
  • Single‑use 8% · sterile 6% · Rx‑only 95% · 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) · 62Length (Millimeter) · 8

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

How many medullary canal orthopaedic reamer, flexible products are registered in the US?

1,032 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medullary canal orthopaedic reamer, flexible", from 31 companies. The largest labeler is Biomet Orthopedics, Llc with 17% of records.

Which FDA product codes apply?

HTO (Reamer), HTO (REAMER), LXH (Orthopedic Manual Surgical Instrument), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented)

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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