Consulting Wallah › Device Explorer › Orthopaedic implants › Polyethylene reverse shoulder prosthesis cup
Device Explorer · FDA GUDID · GMDN 48092

Polyethylene reverse shoulder prosthesis cup

A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

US‑registered devices735in commercial distribution
Companies17labelers on GUDID
Single‑use95%of device records
Sterile100%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tornier, Inc.19827%
Exactech, Inc.9213%
Limacorporate Spa618%
Fx Solutions608%
Smith & Nephew, Inc.608%
Medacta International Sa578%
Waldemar Link Gmbh & Co. Kg547%
Zimmer, Inc.507%

Top labelers

CompanyDevicesShare
Tornier, Inc.19827%
Exactech, Inc.9213%
Limacorporate Spa618%
Fx Solutions608%
Smith & Nephew, Inc.608%
Medacta International Sa578%
Waldemar Link Gmbh & Co. Kg547%
Zimmer, Inc.507%
Fx Shoulder Solutions, Inc.304%
Depuy (Ireland)152%
Aston Medical142%
Biomet Orthopedics, Llc101%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONLINK Embrace Shoulder SystemHUMERIS 135Humeral Cup StabilityHumeral Cup Standard32mm Glenosphere and Humeral CupHumelock II Cemented Reversible ShoulderDuocentric®Alliance Humeral BearingsAlliance Humeral BearingIdentity™ Vivacit-E®Anatomical Shoulder™Arthrex®Identity® Shoulder SystemComprehensive® Vivacit-E®Comprehensive® Prolong®

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 configuration513
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT263
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED216
PHXShoulder Prosthesis, Reverse Configuration184
PAOprosthesis, shoulder, semi-constrained, metal/polymer + addi172
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE172

GMDN & GCC registration

  • GMDN code 48092 · implantable
  • Single‑use 95% · sterile 100% · Rx‑only 97% · 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) · 270Angle (degree) · 24Lumen/Inner Diameter (Millimeter) · 24Height (Millimeter) · 23

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

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

735 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyethylene reverse shoulder prosthesis cup", from 17 companies. The largest labeler is Tornier, Inc. with 27% of records.

Which FDA product codes apply?

PHX (shoulder prosthesis, reverse configuration), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), 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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