World Total Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Signature Orthopaedics Pty Ltd.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for World Total Knee System.

Pre-market Notification Details

Device IDK223062
510k NumberK223062
Device Name:World Total Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2113
ContactDeclan Brazil
CorrespondentDeclan Brazil
Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2113
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-11-04

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.