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Device Explorer · FDA GUDID · GMDN 35670

Total shoulder prosthesis

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically w

US‑registered devices1,562in commercial distribution
Companies18labelers on GUDID
Single‑use80%of device records
Sterile85%labelled sterile
Prescription83%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Shoulder Innovations, Inc.40126%
Medacta International Sa32721%
Encore Medical, L.P.22014%
Zimmer Gmbh1439%
Arthrex, Inc.1087%
Howmedica Osteonics Corp.825%
Stryker Gmbh775%
Endotec, Inc.362%

Top labelers

CompanyDevicesShare
Shoulder Innovations, Inc.40126%
Medacta International Sa32721%
Encore Medical, L.P.22014%
Zimmer Gmbh1439%
Arthrex, Inc.1087%
Howmedica Osteonics Corp.825%
Stryker Gmbh775%
Endotec, Inc.362%
Ingen Orthopedics, L.L.C.322%
Exactech, Inc.302%
Smith & Nephew, Inc.282%
Fx Solutions252%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONReUnionSOLARPROMOSAGILON® XO retentive PE-insert for inverse capAGILON® XO PE-insert for inverse capLINK Embrace Shoulder SystemPRCT2Humelock II Cementless Shoulder SystemARROW®Anatomical Shoulder™Sidus® Stem-Free ShoulderAnatomical Shoulder™ CombinedAnatomical Shoulder#Anatomical Shoulder™ FractureAnatomical Shoulder™ Domelock®

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 CEMENT528
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement466
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED403
PHXShoulder Prosthesis, Reverse Configuration396
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncem351
PHXshoulder prosthesis, reverse configuration241

GMDN & GCC registration

  • GMDN code 35670 · implantable
  • Single‑use 80% · sterile 85% · Rx‑only 83% · 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) · 153Length (Millimeter) · 124Width (Millimeter) · 34Height (Millimeter) · 33Lumen/Inner Diameter (Millimeter) · 4Angle (degree) · 3

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

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

1,562 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total shoulder prosthesis", from 18 companies. The largest labeler is Shoulder Innovations, Inc. with 26% of records.

Which FDA product codes apply?

KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), 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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