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Device Explorer · FDA GUDID · GMDN 58481

Femoral stem prosthesis trial

A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated

US‑registered devices4,504in commercial distribution
Companies30labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc1,12525%
Howmedica Osteonics Corp.55012%
Zimmer, Inc.53212%
United Orthopedic Corp.52312%
Depuy Orthopaedics, Inc.2165%
Depuy (Ireland)2145%
Exactech, Inc.1684%
Smith & Nephew, Inc.1644%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc1,12525%
Howmedica Osteonics Corp.55012%
Zimmer, Inc.53212%
United Orthopedic Corp.52312%
Depuy Orthopaedics, Inc.2165%
Depuy (Ireland)2145%
Exactech, Inc.1684%
Smith & Nephew, Inc.1644%
Waldemar Link Gmbh & Co. Kg1553%
Zimmer Gmbh1523%
Limacorporate Spa1393%
Ortho Development Corporation992%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTInstrumentPOLARSTEMSLR-PLUSSL-PLUSMetafix Hip StemMiniHip StemTriFit TS Blade StemTaperFit Cemented Hip SystemCorin Metafix Hip StemCorin Taper-Fit Total Hip SystemALLIANCE EXACT INSTRUMENTALLIANCE FEMORAL BROACH PROVISIONALBI-METRIC RASP/PROVISIONALTAPERLOC® MICROPLASTY®TAPERLOC MICROPLASTY INSTRUMENTATION

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

FDA product codes

CodeNameDevices
HWTTEMPLATE1,362
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce1,057
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented931
KWZProsthesis, hip, constrained, cemented or uncemented, metal/891
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC890
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT814

GMDN & GCC registration

  • GMDN code 58481 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 86% · 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) · 554Outer Diameter (Millimeter) · 159Height (Millimeter) · 31Lumen/Inner Diameter (Millimeter) · 11

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

How many femoral stem prosthesis trial products are registered in the US?

4,504 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Femoral stem prosthesis trial", from 30 companies. The largest labeler is Biomet Orthopedics, Llc with 25% of records.

Which FDA product codes apply?

HWT (TEMPLATE), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), KWZ (Prosthesis, hip, constrained, cemented or uncemented, metal/)

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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