Consulting Wallah › Device Explorer › Orthopaedic implants › Humeral body prosthesis trial
Device Explorer · FDA GUDID · GMDN 60935

Humeral body prosthesis trial

A copy of a final humeral body 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 connects to a hume

US‑registered devices216in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Exactech, Inc.5525%
Depuy (Ireland)4019%
Tornier, Inc.3014%
Smith & Nephew, Inc.209%
Ascension Orthopedics, Inc.209%
Limacorporate Spa188%
Tornier157%
Arthrex, Inc.105%

Top labelers

CompanyDevicesShare
Exactech, Inc.5525%
Depuy (Ireland)4019%
Tornier, Inc.3014%
Smith & Nephew, Inc.209%
Ascension Orthopedics, Inc.209%
Limacorporate Spa188%
Tornier157%
Arthrex, Inc.105%
Biomet Orthopedics, Llc63%
Zimmer Gmbh21%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aequalis Reversed FractureAequalis Reversed IIAnatomical Shoulder™ Bigliani/Flatow®Arthrex®Comprehensive Segmental Revision System (SRS)Titan Reverse Shoulder SystemTitan Modular Shoulder System 2.5Titan Modular Shoulder SystemComprehensive Segmental Revision SystemTornier HRSTornier PerformAffinitiAscendTornier HRS MaxEquinoxeINHANCE

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

FDA product codes

CodeNameDevices
HWTTEMPLATE113
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED44
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT37
LXHOrthopedic manual surgical instrument25
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE25
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente23

GMDN & GCC registration

  • GMDN code 60935 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 81% · 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) · 54Height (Millimeter) · 13Length (Millimeter) · 4

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

How many humeral body prosthesis trial products are registered in the US?

216 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humeral body prosthesis trial", from 10 companies. The largest labeler is Exactech, Inc. with 25% of records.

Which FDA product codes apply?

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

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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