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Device Explorer · FDA GUDID · GMDN 48093

Reverse shoulder prosthesis head

A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to a

US‑registered devices311in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription95%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Limacorporate Spa6320%
Depuy (Ireland)3411%
Tornier, Inc.3010%
Exactech, Inc.279%
Zimmer, Inc.258%
Restor3D, Inc.227%
Arthrex, Inc.206%
Smith & Nephew, Inc.186%

Top labelers

CompanyDevicesShare
Limacorporate Spa6320%
Depuy (Ireland)3411%
Tornier, Inc.3010%
Exactech, Inc.279%
Zimmer, Inc.258%
Restor3D, Inc.227%
Arthrex, Inc.206%
Smith & Nephew, Inc.186%
Fournitures Hospitalieres Industrie155%
Stryker Gmbh124%
Waldemar Link Gmbh & Co. Kg124%
Implantcast Gmbh103%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONAGILON® XO glenosphere eccentricalAGILON® XO glenosphere neutralAGILON® XO glenosphere eccentrical incl. screwAGILON® XO glenosphere neutral incl. screwLINK Embrace Shoulder System Line ExtensionLINK Embrace Shoulder SystemDuocentric®JARVIS Glenoid Rerverse Shoulder ProsthesisComprehensive Reverse ShoulderTrabecular Metal Reverse Plus™Anatomical Shoulder™Arthrex®Comprehensive® Versa-Dial®AETOS Shoulder SystemTitan 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
PHXshoulder prosthesis, reverse configuration155
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT142
PHXShoulder Prosthesis, Reverse Configuration128
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement79
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED68
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente64

GMDN & GCC registration

  • GMDN code 48093 · implantable
  • Single‑use 100% · sterile 96% · 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) · 65

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

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

311 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reverse shoulder prosthesis head", from 16 companies. The largest labeler is Limacorporate Spa with 20% of records.

Which FDA product codes apply?

PHX (shoulder prosthesis, reverse configuration), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), PHX (Shoulder Prosthesis, Reverse Configuration), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement)

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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