Cleared Traditional

K162026 - EVOLUTION Revision Tibial Base

K162026 is the FDA 510(k) clearance for EVOLUTION Revision Tibial Base by Microport Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K162026 · Microport Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
222d
Days
Class 2
Risk

K162026 is an FDA 510(k) clearance for the EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOL.... 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 March 1, 2017 after a review of 222 days - an extended review 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: 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 K162026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2016
Decision Date March 01, 2017
Days to Decision 222 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
100d slower than avg
Panel avg: 122d · This submission: 222d
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 K162026.
Exactech® Truliant™ Line Extensions
K171045 · Exactech, Inc. · Apr 2017
U2 Total Knee System E-XPE products
K161705 · United Orthopedic Corporation · Mar 2017
GMK Sphere
K162035 · Medacta International S.A. · Mar 2017
Truliant Femoral Components
K170240 · Exactech, Inc. · Feb 2017
U2 Total Knee System, PSA Tibial Insert
K161360 · United Orthopedic Corporation · Feb 2017
Legion Cone System
K162775 · Smith & Nephew, Inc. · Jan 2017