Cleared Traditional

K240043 - EVOLUTION® Hinge Knee System (FDA 510(k) Clearance)

Also includes:
GUARDIAN™ limb Salvage System DCW Modular Distal Femoral System REPIPHYSIS™ Limb Salvage System EVOLUTION® MP Total Knee System EVOLUTION® MP Total Knee System EVOLUTION® MP Adaptive CS Insert EVOLUTION® MP Adaptive PS Tibial Insert EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts EVOLUTION® Revision CCK System ADVANCE® Double High Insert ADVANCE® A-CLASS® Tibial Insert ADVANCE® Knee System ADVANCE® Ultra-Congruent Tibial Inse

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240043 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
87d
Days
Class 2
Risk

K240043 is an FDA 510(k) clearance for the EVOLUTION® Hinge Knee System. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on April 1, 2024 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microport Orthopedics, Inc. devices

Submission Details

510(k) Number K240043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2024
Decision Date April 01, 2024
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 85
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K240043.
Triathlon® Tritanium® Asymmetric Patella
K252898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2025
Stem Extension Line (USTAR II System)
K252303 · United Orthopedic Corporation · Aug 2025
Triathlon® Hinge Knee System
K251665 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2025
ATTUNE™ Revision Hinge Knee
K242871 · Depuy Ireland UC · Nov 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K233980 · Depuy Ireland UC · Mar 2024
EVOLUTION® Hinge Knee System
K230563 · Microport Orthopedics, Inc. · Sep 2023