Cleared Traditional

K142550 - EVOLUTION MP Revision Femur

K142550 is the FDA 510(k) clearance for EVOLUTION MP Revision Femur by Microport Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K142550 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
58d
Days
Class 2
Risk

K142550 is an FDA 510(k) clearance for the EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments. 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 November 7, 2014 after a review of 58 days - a notably fast clearance cycle.

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: 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 K142550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date November 07, 2014
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 785
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K142550.
Arthrex iBalance Patella Implant, Dome
K143047 · Arthrex, Inc. · Nov 2014
JOURNEY II XR KNEE SYSTEM
K141471 · Smith & Nephew, Inc. · Nov 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K142161 · Conformis, Inc. · Nov 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · Smith & Nephew, Inc. · Aug 2014
GMK SPHERE EXTENSION
K140826 · Medacta International · Jul 2014
EXPRT REVISION KNEE
K140830 · Encore Medical, L.P. · Jul 2014