Consulting Wallah › Device Explorer › Orthopaedic implants › Humeral stem prosthesis trial, reusable
Device Explorer · FDA GUDID · GMDN 60936

Humeral stem prosthesis trial, reusable

A copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made

US‑registered devices771in commercial distribution
Companies13labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc23230%
Limacorporate Spa11715%
Tornier, Inc.7410%
Exactech, Inc.567%
Smith & Nephew, Inc.506%
Depuy (Ireland)496%
Implantcast Gmbh456%
Ascension Orthopedics, Inc.425%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc23230%
Limacorporate Spa11715%
Tornier, Inc.7410%
Exactech, Inc.567%
Smith & Nephew, Inc.506%
Depuy (Ireland)496%
Implantcast Gmbh456%
Ascension Orthopedics, Inc.425%
Howmedica Osteonics Corp.263%
Tornier233%
Waldemar Link Gmbh & Co. Kg223%
Arthrex, Inc.203%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTREUNIONAGILON® trial metaphyseal component omarthrosisAGILON® trial metaphyseal component TraumaAGILON® trial stem adapterAGILON® trial stemAGILON® trial screwAGILON® trial extension pieceLink Embrace Shoulder System - InstrumentsAequalis Reversed FractureAequalis Reversed IIAequalis FractureArthrex®Comprehensive® Revision Shoulder SystemComprehensive® Shoulder SystemComprehensive® SRS Instrument

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

FDA product codes

CodeNameDevices
HWTTEMPLATE308
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT229
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE198
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM196
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED139
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented114

GMDN & GCC registration

  • GMDN code 60936 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 88% · 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) · 106Length (Millimeter) · 58Lumen/Inner Diameter (Millimeter) · 17Height (Millimeter) · 8

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

How many humeral stem prosthesis trial, reusable products are registered in the US?

771 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humeral stem prosthesis trial, reusable", from 13 companies. The largest labeler is Biomet Orthopedics, Llc with 30% of records.

Which FDA product codes apply?

HWT (TEMPLATE), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), KWT (PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE), MBF (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM)

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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