Class Class II

Modular Rotating Hinge Knee Systems and Compatible Components (K223069)

K223069 2023-04-21 Traditional
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Description

Modular Rotating Hinge Knee Systems and Compatible Components by Howmedica Osteonics Corp., Dba Stryker Orthopaedics, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223069
Clearance Date2023-04-21
Clearance TypeTraditional
Product CodeKRO
Regulation Number888.3510

Categories

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Predicate lineage for K223069

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. Modular Rotating Hinge Knee Systems and Compatible Components (K223069) cites 0 predicate devices and is itself cited by 1 later device.

Later devices that cite this one as their predicate

Devices that cite K223069
K numberDeviceApplicantYear
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker2023

Trace the full predicate network for K223069

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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