Cleared Traditional

K243574 - Evolution Total Knee Systems - Kinemati...

K243574 is the FDA 510(k) clearance for Evolution Total Knee Systems - Kinemati... by Microport Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K243574 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
91d
Days
Class 2
Risk

K243574 is an FDA 510(k) clearance for the Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Techn.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on February 18, 2025 after a review of 91 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. 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 Microport Orthopedics, Inc. devices

Submission Details

510(k) Number K243574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2024
Decision Date February 18, 2025
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 762
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K243574.
Freedom Total Knee System (All-poly Tibial Plate)
K250382 · Maxx Orthopedics, Inc. · Mar 2025
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
K243724 · Zimmer, Inc. · Mar 2025
MedalOne Total Knee System
K244039 · Suzhou Microport Orthorecon Co., Ltd. · Feb 2025
Scorpio Universal Dome Patella
K243817 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2025
Consensus Knee System with TiNbN
K241180 · Shalby Advanced Technologies · Jan 2025
Initia Knee System
K243295 · Kyocera Medical Technologies, Inc. · Jan 2025