Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated shoulder humeral stem prosthesis
Device Explorer · FDA GUDID · GMDN 34197

Uncoated shoulder humeral stem prosthesis

A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrom

US‑registered devices364in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Waldemar Link Gmbh & Co. Kg6117%
Arthrex, Inc.5515%
Stryker Gmbh4412%
Zimmer, Inc.3911%
Zimmer Gmbh3810%
Implantcast Gmbh349%
Tornier, Inc.247%
Limacorporate Spa226%

Top labelers

CompanyDevicesShare
Waldemar Link Gmbh & Co. Kg6117%
Arthrex, Inc.5515%
Stryker Gmbh4412%
Zimmer, Inc.3911%
Zimmer Gmbh3810%
Implantcast Gmbh349%
Tornier, Inc.247%
Limacorporate Spa226%
Fx Solutions195%
Smith & Nephew, Inc.62%
Ascension Orthopedics, Inc.62%
Aston Medical51%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONMRSAGILON® stem cementlessEmbrace Shoulder SystemLINK Embrace Shoulder SystemEasytech Anatomical Shoulder SystemHumelock Reversed ShoulderHumelock II Cemented Shoulder SystemPRCT2Duocentric®Anatomical Shoulder™Trabecular Metal®Bigliani/Flatow®Arthrex®Titan Modular Shoulder SystemBI-ANGULAR SYSTEM

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED262
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT231
PHXshoulder prosthesis, reverse configuration125
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE96
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented90
PAOprosthesis, shoulder, semi-constrained, metal/polymer + addi61

GMDN & GCC registration

  • GMDN code 34197 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · 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) · 119Length (Millimeter) · 66Angle (degree) · 23

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

How many uncoated shoulder humeral stem prosthesis products are registered in the US?

364 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated shoulder humeral stem prosthesis", from 15 companies. The largest labeler is Waldemar Link Gmbh & Co. Kg with 17% of records.

Which FDA product codes apply?

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

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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