Cleared Traditional

K170573 - Empowr CR Knee Tibial Insert

K170573 is an FDA 510(k) clearance for Empowr CR Knee Tibial Insert, 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 93-day FDA review.

K170573 · Encore Medical, L.P. · Orthopedic device
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May 2017
Decision
93d
Days
Class 2
Risk

K170573 is an FDA 510(k) clearance for the Empowr CR Knee Tibial Insert. 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 31, 2017 after a review of 93 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 - K170573

510(k) Number K170573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date May 31, 2017
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 887
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K170573.
Genius Total Knee System
K170613 · Signature Orthopaedics Pty, Ltd. · Jul 2017
Unity Total Knee System
K170808 · Corin U.S.A. Limited · Jul 2017
ATTUNE Cemented Tibial Base, Fixed Bearing
K170806 · Depuy(Ireland) · Jun 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · Smith & Nephew, Inc. · May 2017
ANTHEM CR Total Knee System
K170648 · Smith & Nephew, Inc. · May 2017
Exactech® Truliant™ Line Extensions
K171045 · Exactech, Inc. · Apr 2017