Consulting Wallah › Device Explorer › Orthopaedic implants › Reverse shoulder head prosthesis trial
Device Explorer · FDA GUDID · GMDN 60931

Reverse shoulder head prosthesis trial

A copy of a final reverse shoulder prosthesis head 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 hemisp

US‑registered devices191in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Limacorporate Spa5328%
Depuy (Ireland)3518%
Exactech, Inc.2010%
Zimmer, Inc.189%
Implantcast Gmbh147%
Arthrex, Inc.137%
Smith & Nephew, Inc.137%
Stryker Gmbh126%

Top labelers

CompanyDevicesShare
Limacorporate Spa5328%
Depuy (Ireland)3518%
Exactech, Inc.2010%
Zimmer, Inc.189%
Implantcast Gmbh147%
Arthrex, Inc.137%
Smith & Nephew, Inc.137%
Stryker Gmbh126%
Biomet Orthopedics, Llc105%
Encore Medical, L.P.32%

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

Brand names on the register (sample)

REUNIONAGILON® XO trial cap inverseAGILON® XO trial glenosphereCOMP AUG BSPLT TRIAL-GUIDE LGCOMP AUG BSPLT TRIAL-GUIDE MDCOMP AUG BSPLT TRIAL-GUIDE SMTrabecular Metal Reverse Plus™Arthrex®Comprehensive® Reverse ShoulderComprehensive Reverse Shoulder Mini BaseplateComprehensive® Versa-Dial®AETOS Shoulder SystemTitan Reverse Shoulder SystemCOMPREHENSIVE® REVERSE SHOULDERDJO SURGICALEquinoxe

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

FDA product codes

CodeNameDevices
HWTTEMPLATE64
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT38
PHXshoulder prosthesis, reverse configuration34
PHXShoulder Prosthesis, Reverse Configuration32
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement28
LXHOrthopedic Manual Surgical Instrument24

GMDN & GCC registration

  • GMDN code 60931 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 74% · 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) · 18Height (Millimeter) · 2

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

How many reverse shoulder head prosthesis trial products are registered in the US?

191 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reverse shoulder head prosthesis trial", from 10 companies. The largest labeler is Limacorporate Spa with 28% of records.

Which FDA product codes apply?

HWT (TEMPLATE), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), PHX (shoulder prosthesis, reverse configuration), PHX (Shoulder Prosthesis, Reverse Configuration)

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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