Consulting Wallah › Device Explorer › Orthopaedic implants › Shoulder glenoid fossa prosthesis trial
Device Explorer · FDA GUDID · GMDN 60932

Shoulder glenoid fossa prosthesis trial

A copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-l

US‑registered devices566in commercial distribution
Companies14labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Tornier, Inc.9316%
Smith & Nephew, Inc.8715%
Depuy (Ireland)5710%
Biomet Orthopedics, Llc448%
Encore Medical, L.P.438%
Arthrex, Inc.387%
Exactech, Inc.346%
Zimmer, Inc.326%

Top labelers

CompanyDevicesShare
Tornier, Inc.9316%
Smith & Nephew, Inc.8715%
Depuy (Ireland)5710%
Biomet Orthopedics, Llc448%
Encore Medical, L.P.438%
Arthrex, Inc.387%
Exactech, Inc.346%
Zimmer, Inc.326%
Limacorporate Spa315%
Stryker Gmbh305%
Ascension Orthopedics, Inc.295%
Waldemar Link Gmbh & Co. Kg214%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONPROMOSLINK Embrace Shoulder System Line ExtensionLink Embrace Shoulder System - InstrumentsAlliance®Arthrex®Hybrid® Glenoid InstrumentationComprehensive® InstrumentsComprehensive Reverse Shoulder SystemModular Hybrid GlenoidAETOS Shoulder SystemTitan Reverse Shoulder SystemTitan Modular Shoulder System 2.5Titan Modular Shoulder SystemBIO-MODULAR(R) SHOULDERHYBRID(TM) GLENOID INSTRUMENTATION

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

FDA product codes

CodeNameDevices
HWTTEMPLATE299
LXHOrthopedic manual surgical instrument98
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT98
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE63
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED46
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente36

GMDN & GCC registration

  • GMDN code 60932 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 90% · 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

Angle (degree) · 96Outer Diameter (Millimeter) · 14Length (Millimeter) · 12

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

How many shoulder glenoid fossa prosthesis trial products are registered in the US?

566 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoulder glenoid fossa prosthesis trial", from 14 companies. The largest labeler is Tornier, Inc. with 16% of records.

Which FDA product codes apply?

HWT (TEMPLATE), LXH (Orthopedic manual surgical instrument), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), 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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