Consulting Wallah › Device Explorer › Orthopaedic implants › Coated shoulder humeral stem prosthesis
Device Explorer · FDA GUDID · GMDN 39702

Coated 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 devices997in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tornier, Inc.30230%
Biomet Orthopedics, Llc27327%
Zimmer, Inc.10711%
Limacorporate Spa495%
Fx Shoulder Solutions, Inc.384%
Depuy (Ireland)303%
Howmedica Osteonics Corp.263%
Fournitures Hospitalieres Industrie263%

Top labelers

CompanyDevicesShare
Tornier, Inc.30230%
Biomet Orthopedics, Llc27327%
Zimmer, Inc.10711%
Limacorporate Spa495%
Fx Shoulder Solutions, Inc.384%
Depuy (Ireland)303%
Howmedica Osteonics Corp.263%
Fournitures Hospitalieres Industrie263%
Stryker Gmbh253%
Waldemar Link Gmbh & Co. Kg222%
Smith & Nephew, Inc.192%
Exactech, Inc.192%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONReUnionMRSLINK Embrace Shoulder SystemHumeris ShoulderHUMELOCK REVERSEDHumelock II Cementless Shoulder SystemAEQUALIS-FRACTUREDuocentric®JARVIS METAPHYSEAL STEMJARVIS Diaphyseal Stem StandardARROW Short Stem Humeral SystemIdentity HumeralOsseoFit™ Stemless ShoulderIdentity™Trabecular Metal®

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 CEMENT880
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED781
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE510
PHXshoulder prosthesis, reverse configuration394
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM348
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented178

GMDN & GCC registration

  • GMDN code 39702 · implantable
  • Single‑use 100% · 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) · 302Length (Millimeter) · 292Angle (degree) · 184Circumference (Millimeter) · 10

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

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

997 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated shoulder humeral stem prosthesis", from 19 companies. The largest labeler is Tornier, Inc. with 30% of records.

Which FDA product codes apply?

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