Consulting Wallah › Device Explorer › Other devices › Medullary canal orthopaedic reamer, rigid
Device Explorer · FDA GUDID · GMDN 45115

Medullary canal orthopaedic reamer, rigid

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, cyli

US‑registered devices2,943in commercial distribution
Companies43labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Smith & Nephew, Inc.54218%
Biomet Orthopedics, Llc35512%
Howmedica Osteonics Corp.31811%
Waldemar Link Gmbh & Co. Kg30210%
Depuy (Ireland)2107%
United Orthopedic Corp.1515%
Exactech, Inc.1455%
Shalby Advanced Technologies, Inc.1314%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.54218%
Biomet Orthopedics, Llc35512%
Howmedica Osteonics Corp.31811%
Waldemar Link Gmbh & Co. Kg30210%
Depuy (Ireland)2107%
United Orthopedic Corp.1515%
Exactech, Inc.1455%
Shalby Advanced Technologies, Inc.1314%
Depuy Orthopaedics, Inc.1314%
Limacorporate Spa1044%
Ortho Development Corporation863%
Zimmer, Inc.572%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2 ALPHAT2INSTRUMENTGAMMANAREUNIONVARIAXPOLARSTEMPro-X1ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS STERILE DRILL BITSOXFORD ANKLE FUSION NAIL(AFN) SYSTEMCorin Metafix Hip StemResolve Modular Revision StemU1™ HipU2™ Knee

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

FDA product codes

CodeNameDevices
HTOREAMER1,205
HTOReamer463
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce346
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT266
JDGProsthesis, hip, femoral component, cemented, metal215
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented185

GMDN & GCC registration

  • GMDN code 45115 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 84% · 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) · 322Length (Millimeter) · 102Angle (degree) · 30Lumen/Inner Diameter (Millimeter) · 13Length (Inch) · 4Outer Diameter (Inch) · 4

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

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

2,943 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medullary canal orthopaedic reamer, rigid", from 43 companies. The largest labeler is Smith & Nephew, Inc. with 18% of records.

Which FDA product codes apply?

HTO (REAMER), HTO (Reamer), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), 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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