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Device Explorer · FDA GUDID · GMDN 33711

Total reverse shoulder prosthesis

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treat

US‑registered devices1,195in commercial distribution
Companies14labelers on GUDID
Single‑use94%of device records
Sterile96%labelled sterile
Prescription82%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tornier28624%
Arthrex, Inc.21018%
Encore Medical, L.P.19216%
Catalyst Orthoscience Inc.11510%
Fournitures Hospitalieres Industrie847%
Depuy (Ireland)837%
Restor3D, Inc.827%
Zimmer Gmbh504%

Top labelers

CompanyDevicesShare
Tornier28624%
Arthrex, Inc.21018%
Encore Medical, L.P.19216%
Catalyst Orthoscience Inc.11510%
Fournitures Hospitalieres Industrie847%
Depuy (Ireland)837%
Restor3D, Inc.827%
Zimmer Gmbh504%
Arthrosurface Incorporated434%
Ingen Orthopedics, L.L.C.292%
Implantcast Gmbh91%
Biomet Orthopedics, Llc71%

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

Brand names on the register (sample)

AGILON® XO inverse cap baseAEQUALIS REVERSED FRACTURETornier Flex Shoulder SystemAEQUALIS REVERSED IIAEQUALIS REVERSEDAEQUALIS REVERSED FX / ADAPTERTORNIER - SCREWARROW Off-Centred Humeral InsertARROW® ANATOMICAL POROUS GLENOIDARROW®ASHCOM™ ShoulderAnatomical Shoulder™ ReverseInverse/ReverseAnatomical Shoulder#Anatomical Shoulder™DJO SURGICAL

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 CEMENT800
PHXshoulder prosthesis, reverse configuration536
PHXShoulder Prosthesis, Reverse Configuration426
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED392
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement115
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente73

GMDN & GCC registration

  • GMDN code 33711 · implantable
  • Single‑use 94% · sterile 96% · Rx‑only 82% · 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) · 374Angle (degree) · 326Length (Millimeter) · 325Height (Millimeter) · 9

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

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

1,195 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total reverse shoulder prosthesis", from 14 companies. The largest labeler is Tornier with 24% of records.

Which FDA product codes apply?

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

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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