Class Class II

Freedom® Total Knee System – Porous Tibial Base Plate (K241597)

K241597 2025-02-13 Traditional
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Description

Freedom® Total Knee System - Porous Tibial Base Plate by Maxx Orthopedics, Inc., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241597
Clearance Date2025-02-13
Clearance TypeTraditional
Product CodeMBH
Regulation Number888.3565

Categories

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Predicate lineage for K241597

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. Freedom® Total Knee System – Porous Tibial Base Plate (K241597) cites 6 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230321Persona™ Personalized Knee SystemZimmer, Inc.2023
K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.2021
K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.2018
K171991EMPOWR Porous Knee SystemEncore Medical L.P.2017
K090411FREEDOM METAL BACKED TIBIAL COMPONENTMaxx Orthopedics, Inc.2009
K030623SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEMSmith & Nephew, Inc.2003

Later devices that cite this one as their predicate

Devices that cite K241597
K numberDeviceApplicantYear
K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.2025

Trace the full predicate network for K241597

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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