Class Class II

Triathlon® Total Knee System – Triathlon® Pro Posterior Stabilized (PS) Femoral Component (K230952)

K230952 2023-06-02 Traditional
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Description

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component by Howmedica Osteonics Corp., Dba Stryker Orthopaedics, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230952
Clearance Date2023-06-02
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560

Categories

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Predicate lineage for K230952

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Triathlon® Total Knee System – Triathlon® Pro Posterior Stabilized (PS) Femoral Component (K230952) cites 5 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica...2019
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris...Stryker Orthopaedics2017
K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker Orthopaedics2014
K123907PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMO...Biomet Manufacturing Corp2013
K042993TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENTHowmedica Osteonics Corp.2005

Later devices that cite this one as their predicate

Devices that cite K230952
K numberDeviceApplicantYear
K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized F...Howmedica Osteonics Corp., Dba Stry...2024

Trace the full predicate network for K230952

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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