Consulting Wallah › Device Explorer › Orthopaedic implants › Humeral head prosthesis trial, reusable
Device Explorer · FDA GUDID · GMDN 58784

Humeral head prosthesis trial, reusable

A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the i

US‑registered devices1,310in commercial distribution
Companies17labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc30423%
Tornier, Inc.15912%
Stryker Gmbh1149%
Zimmer, Inc.1088%
Exactech, Inc.1038%
Limacorporate Spa937%
Depuy (Ireland)846%
Zimmer Gmbh725%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc30423%
Tornier, Inc.15912%
Stryker Gmbh1149%
Zimmer, Inc.1088%
Exactech, Inc.1038%
Limacorporate Spa937%
Depuy (Ireland)846%
Zimmer Gmbh725%
Ascension Orthopedics, Inc.605%
Arthrex, Inc.564%
Smith & Nephew, Inc.494%
Implantcast Gmbh474%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REUNIONN/AINSTRUMENTAGILON® XO trial glenoidAGILON®AGILON® XO retentive trial capAGILON® trial captrial head taper 12/14mmAGILON® CTA trial capLink Embrace Shoulder System - InstrumentsTornier FlexAequalis Reversed IIT.E.S.S. HUM OFFSET TRIAL HEADT.E.S.S. HUM HEAD TRIALNEERVersa-Dial® Shoulder System

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

FDA product codes

CodeNameDevices
HWTTEMPLATE677
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT323
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED225
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE195
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented136
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT121

GMDN & GCC registration

  • GMDN code 58784 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 89% · 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) · 214Height (Millimeter) · 150Width (Millimeter) · 25Angle (degree) · 4

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

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

1,310 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humeral head prosthesis trial, reusable", from 17 companies. The largest labeler is Biomet Orthopedics, Llc with 23% of records.

Which FDA product codes apply?

HWT (TEMPLATE), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), 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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