Consulting Wallah › Device Explorer › Orthopaedic implants › Knee femur prosthesis trial, reusable
Device Explorer · FDA GUDID · GMDN 58715

Knee femur prosthesis trial, reusable

A copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes

US‑registered devices7,236in commercial distribution
Companies30labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc1,40019%
Zimmer, Inc.95313%
Smith & Nephew, Inc.74710%
Howmedica Osteonics Corp.5337%
Waldemar Link Gmbh & Co. Kg5037%
Ortho Development Corporation4977%
United Orthopedic Corp.4166%
Depuy (Ireland)3515%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc1,40019%
Zimmer, Inc.95313%
Smith & Nephew, Inc.74710%
Howmedica Osteonics Corp.5337%
Waldemar Link Gmbh & Co. Kg5037%
Ortho Development Corporation4977%
United Orthopedic Corp.4166%
Depuy (Ireland)3515%
Corentec Co., Ltd3104%
Exactech, Inc.2864%
Omni Life Science, Inc.1863%
Depuy Orthopaedics, Inc.1652%

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

Brand names on the register (sample)

INSTRUMENTSPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SISPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SI

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

FDA product codes

CodeNameDevices
HWTTEMPLATE2,389
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM1,656
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem913
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 878
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN839
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT838

GMDN & GCC registration

  • GMDN code 58715 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 83% · 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) · 221Height (Millimeter) · 143Outer Diameter (Millimeter) · 54Angle (degree) · 9Width (Millimeter) · 4

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

How many knee femur prosthesis trial, reusable products are registered in the US?

7,236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee femur prosthesis trial, reusable", from 30 companies. The largest labeler is Biomet Orthopedics, Llc with 19% of records.

Which FDA product codes apply?

HWT (TEMPLATE), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, )

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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