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Device Explorer · FDA GUDID · GMDN 60927

Glenoid orthopaedic reamer

An orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer

US‑registered devices254in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Exactech, Inc.8333%
Limacorporate Spa4417%
Stryker Gmbh3213%
Zimmer, Inc.2610%
Biomet Orthopedics, Llc229%
Tornier, Inc.166%
Encore Medical, L.P.114%
Orthosoft Inc94%

Top labelers

CompanyDevicesShare
Exactech, Inc.8333%
Limacorporate Spa4417%
Stryker Gmbh3213%
Zimmer, Inc.2610%
Biomet Orthopedics, Llc229%
Tornier, Inc.166%
Encore Medical, L.P.114%
Orthosoft Inc94%
Waldemar Link Gmbh & Co. Kg73%
Howmedica Osteonics Corp.42%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONInstrumentINSTRUMENTLINK Embrace Shoulder System Line ExtensionLink Embrace Shoulder System - InstrumentsIdentity Inlay Small Tooth ReamerROSA® ShoulderAllianceComprehensiveOFF AXIS COMP MINI REAMER 6-SPOKE LGOFF AXIS COMP MINI REAMER 6-SPOKE MDOFF AXIS COMP MINI REAMER 6-SPOKE SMAlliance Non-Cann Ctr Post DrOff Axis Comp Mini Gd InserterOff Axis Comp Mini Reamer Gd LgOff Axis Comp Mini Reamer Gd Med

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

FDA product codes

CodeNameDevices
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT133
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE122
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED100
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente63
PHXshoulder prosthesis, reverse configuration53
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement51

GMDN & GCC registration

  • GMDN code 60927 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 98% · 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) · 20Width (Millimeter) · 3

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

No closely related category with 50+ devices.

How many glenoid orthopaedic reamer products are registered in the US?

254 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glenoid orthopaedic reamer", from 10 companies. The largest labeler is Exactech, Inc. with 33% of records.

Which FDA product codes apply?

KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), KWT (PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE), HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente)

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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