Cleared Traditional

K182251 - EVOLUTION NitrX Medial-Pivot Knee

K182251 is the FDA 510(k) clearance for EVOLUTION NitrX Medial-Pivot Knee by Mircoport Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K182251 · Mircoport Orthopedics, Inc. · Orthopedic device
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May 2019
Decision
269d
Days
Class 2
Risk

K182251 is an FDA 510(k) clearance for the EVOLUTION NitrX Medial-Pivot Knee. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Mircoport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on May 16, 2019 after a review of 269 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 Mircoport Orthopedics, Inc. devices

Submission Details

510(k) Number K182251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2018
Decision Date May 16, 2019
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 780
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