Cleared Traditional

K241597 - Freedom Total Knee System - Porous Tibi...

K241597 is the FDA 510(k) clearance for Freedom Total Knee System - Porous Tibi... by Maxx Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K241597 · Maxx Orthopedics, Inc. · Orthopedic device
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Feb 2025
Decision
255d
Days
Class 2
Risk

K241597 is an FDA 510(k) clearance for the Freedom® Total Knee System - Porous Tibial Base Plate. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on February 13, 2025 after a review of 255 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Maxx Orthopedics, Inc. devices

Submission Details

510(k) Number K241597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2024
Decision Date February 13, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 122d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 Consultant

Secure BioMed Evaluations
Justin Gracyalny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K241597.
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