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Freedom Total Knee System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240863

by Maxx Orthopedics, Inc.

Identifiers

510(k) Number
K240863 FDA 510(k)
FDA Product Code
JWH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Freedom Total Knee System is a total knee arthroplasty device designed for primary total knee replacement. It is classified under the FDA’s orthopedic product category and is intended to restore function and alleviate pain in patients with degenerative joint disease or trauma-related knee damage.

This system is supplied sterile and intended for single-use, with components available in various sizes to accommodate different patient anatomies. It is approved under FDA 510(k) clearance (K240863) and is intended for use in orthopedic surgical settings. The device adheres to traditional review standards and is distributed by Maxx Orthopedics, Inc., based in Norristown, Pennsylvania.

Frequently asked questions

What types of knee conditions is the Freedom® Total Knee System designed to address in clinical practice?

The Freedom® Total Knee System is specifically designed for primary total knee replacement to restore function and relieve pain in patients suffering from degenerative joint disease (such as osteoarthritis) or trauma-related knee damage. It is not intended for revision surgeries or other specialized knee conditions.

Is the Freedom® Total Knee System intended for reuse in the operating room, or is it single-use only?

The Freedom® Total Knee System is explicitly intended for single-use only. This ensures sterility and reduces the risk of cross-contamination in surgical settings, aligning with best practices for orthopedic implants.

How are the components of the Freedom® Total Knee System supplied, and do they come in multiple sizes?

The system is supplied sterile and includes components available in various sizes to accommodate different patient anatomies. This modularity allows surgeons to select the appropriate fit for each patient during surgery.

What regulatory pathway was followed for FDA clearance of the Freedom® Total Knee System, and who is the manufacturer?

The Freedom® Total Knee System received FDA clearance through a 510(k) submission (K240863) under the Traditional Review pathway, classified under the orthopedic product category (OR). It was submitted by Maxx Orthopedics, Inc. based in Norristown, Pennsylvania.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Freedom™ Knee Solutions | Maxx Orthopedics, Maxx Orthopedics | Advanced Orthopedic Solutions, Freedom® Total Knee System Surgical Technique Guide | Maxx Orthopedics, Joints - Maxx Health

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maxx Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K240863 24 fields · synced Sep 19, 2026