Cleared Traditional

K160342 - EMPOWR PS Knee System

K160342 is an FDA 510(k) clearance for EMPOWR PS Knee System, manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K160342 · Encore Medical, L.P. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
101d
Days
Class 2
Risk

K160342 is an FDA 510(k) clearance for the EMPOWR PS Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on May 19, 2016 after a review of 101 days - within the typical 510(k) review window.

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 Encore Medical, L.P. devices

FDA 510(k) Submission Details - K160342

510(k) Number K160342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date May 19, 2016
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K160342.
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
K161668 · Conformis, Inc. · Jul 2016
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
K161366 · Conformis, Inc. · Jun 2016
ATTUNE Revision Knee System
K160700 · Depuy(Ireland) · Jun 2016
All Poly Tibial Component
K152430 · United Orthopedic Corporation · Apr 2016
Optetrak Logic Metaphyseal Cones
K153595 · Exactech, Inc. · Mar 2016
iTotal Cruciate Retaining (CR) Knee Replacement System
K153721 · Conformis, Inc. · Mar 2016