Consulting Wallah › Device Explorer › Orthopaedic implants › Patella prosthesis trial
Device Explorer · FDA GUDID · GMDN 58714

Patella prosthesis trial

A copy of a final patella 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, and to check that patellar ligament balancing

US‑registered devices682in commercial distribution
Companies28labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Smith & Nephew, Inc.12318%
United Orthopedic Corp.9213%
Biomet Orthopedics, Llc8512%
Howmedica Osteonics Corp.487%
Zimmer, Inc.406%
Corentec Co., Ltd386%
Depuy (Ireland)355%
Depuy Orthopaedics, Inc.345%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.12318%
United Orthopedic Corp.9213%
Biomet Orthopedics, Llc8512%
Howmedica Osteonics Corp.487%
Zimmer, Inc.406%
Corentec Co., Ltd386%
Depuy (Ireland)355%
Depuy Orthopaedics, Inc.345%
Waldemar Link Gmbh & Co. Kg223%
Exactech, Inc.213%
Conformis, Inc.162%
Omni Life Science, Inc.152%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTUnity Total Knee SystemRotaglide+ Modular Knee System with Fixed MeniscResolve Modular Revision StemU2 Total Knee SystemResolve Modular Revision Hip StemU2™ KneeUKNEE™ACS®LINK Instruments - Trial implants and size gaugeLINK InstrumentLinkSymphoKnee - InstrumentsEndo-Model Knee System - InstrumentsJOURNEYGENESIS IIPROFIX

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

FDA product codes

CodeNameDevices
HWTTEMPLATE171
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM152
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem122
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN85
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT80
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem73

GMDN & GCC registration

  • GMDN code 58714 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 85% · 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) · 52Height (Millimeter) · 6

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

How many patella prosthesis trial products are registered in the US?

682 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patella prosthesis trial", from 28 companies. The largest labeler is Smith & Nephew, Inc. with 18% of records.

Which FDA product codes apply?

HWT (TEMPLATE), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN)

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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