Class Class II

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056)

K222056 2023-01-26 Traditional
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Description

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee by Howmedica Osteonics Corp., Dba Stryker Orthopaedics, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222056
Clearance Date2023-01-26
Clearance TypeTraditional
Product CodeJDI
Regulation Number888.3350

Categories

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Predicate lineage for K222056

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. Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056) cites 1 predicate device and is itself cited by 3 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K023087GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)Howmedica Osteonics Corp.2002

Later devices that cite this one as their predicate

Devices that cite K222056
K numberDeviceApplicantYear
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stry...2025
K241716Global Modular Replacement System, Modular Replacement Syst...Howmedica Osteonics Corp., Dba Stry...2024
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. St...2023

Trace the full predicate network for K222056

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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