Cleared Special

K182574 - Freedom Ultra-Congruent CR Tibial Liner

K182574 is an FDA 510(k) clearance for Freedom Ultra-Congruent CR Tibial Liner, manufactured by Maxx Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 126-day FDA review.

K182574 · Maxx Orthopedics, Inc. · Orthopedic device
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Jan 2019
Decision
126d
Days
Class 2
Risk

K182574 is an FDA 510(k) clearance for the Freedom Ultra-Congruent CR Tibial Liner. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on January 22, 2019 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182574

510(k) Number K182574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date January 22, 2019
Days to Decision 126 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Modification to existing cleared device.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 921
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K182574.
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K182574 · Freedom Ultra-Congruent CR Tibial Liner
Download PDF Maxx Orthopedics, Inc.