Triathlon Total KneeSystem

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

Howmedica Osteonics Corp. Dba Stryker Orthopaedics

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. Dba Stryker Orthopaedics with the FDA for Triathlon Total Kneesystem.

Pre-market Notification Details

Device IDK201343
510k NumberK201343
Device Name:Triathlon Total KneeSystem
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah,  NJ  07430
ContactShikha Khandelwal
CorrespondentShikha Khandelwal
Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah,  NJ  07430
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-07-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.