Cleared Traditional

Evolution? Total Knee Systems - Kinematic Alignment Instrumentation and Technique

K243574 · Microport Orthopedics, Inc. · Orthopedic
Feb 2025
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K243574 is an FDA 510(k) clearance for the Evolution? Total Knee Systems - Kinematic Alignment Instrumentation and Technique, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on February 18, 2025, 91 days after receiving the submission on November 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K243574 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

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