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Device Explorer · FDA GUDID · GMDN 60511

Reverse shoulder prosthesis body

A sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reve

US‑registered devices165in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.6640%
Depuy (Ireland)3119%
Exactech, Inc.2012%
Limacorporate Spa1610%
Biomet Orthopedics, Llc148%
Aston Medical85%
Waldemar Link Gmbh & Co. Kg42%
Smith & Nephew, Inc.32%

Top labelers

CompanyDevicesShare
Zimmer, Inc.6640%
Depuy (Ireland)3119%
Exactech, Inc.2012%
Limacorporate Spa1610%
Biomet Orthopedics, Llc148%
Aston Medical85%
Waldemar Link Gmbh & Co. Kg42%
Smith & Nephew, Inc.32%
Ascension Orthopedics, Inc.32%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LINK Embrace Shoulder System Line ExtensionLINK Embrace Shoulder SystemDuocentric®Identity® Shoulder SystemComprehensive Reverse ShoulderIdentity™Trabecular Metal®Trabecular Metal™Bio-Modular® Reverse ShoulderComprehensive®Titan Reverse Shoulder SystemBIO-MODULAR REVERSE SHOULDERComprehensive® Reverse ShoulderEquinoxe®EquinoxeINHANCE

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 CEMENT130
PHXshoulder prosthesis, reverse configuration115
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE92
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED70
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM67
PAOprosthesis, shoulder, semi-constrained, metal/polymer + addi50

GMDN & GCC registration

  • GMDN code 60511 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

Height (Millimeter) · 12Length (Millimeter) · 2

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

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

165 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reverse shoulder prosthesis body", from 9 companies. The largest labeler is Zimmer, Inc. with 40% of records.

Which FDA product codes apply?

KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), PHX (shoulder prosthesis, reverse configuration), KWT (PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE), 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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