Consulting Wallah › Device Explorer › Orthopaedic implants › Elbow humerus prosthesis trial
Device Explorer · FDA GUDID · GMDN 58750

Elbow humerus prosthesis trial

A copy of a final humerus prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct size, length, condyle positioning, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of gradua

US‑registered devices114in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Tornier, Inc.4741%
Biomet Orthopedics, Llc2219%
Zimmer, Inc.2118%
Ascension Orthopedics, Inc.1816%
Smith & Nephew, Inc.65%

Top labelers

CompanyDevicesShare
Tornier, Inc.4741%
Biomet Orthopedics, Llc2219%
Zimmer, Inc.2118%
Ascension Orthopedics, Inc.1816%
Smith & Nephew, Inc.65%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nexel®NAComprehensive® SRS InstrumentModular Radial Head (MRH) SystemCOMPREHENSIVE® SRS / NEXELCOMPREHENSIVE SRS INSTRUMENTDISCOVERY MOSAICTornier LatitudeIntegra®

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

FDA product codes

CodeNameDevices
LXHOrthopedic manual surgical instrument47
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED27
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER24
HWTTEMPLATE16
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE16
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM16

GMDN & GCC registration

  • GMDN code 58750 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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

Length (Millimeter) · 28Length (Inch) · 10

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

How many elbow humerus prosthesis trial products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Elbow humerus prosthesis trial", from 5 companies. The largest labeler is Tornier, Inc. with 41% of records.

Which FDA product codes apply?

LXH (Orthopedic manual surgical instrument), JDC (PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED), KWI (PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER), HWT (TEMPLATE)

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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