Cleared Traditional

K213793 - EMPOWR Revision Knee

K213793 is the FDA 510(k) clearance for EMPOWR Revision Knee by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K213793 · Encore Medical, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
116d
Days
Class 2
Risk

K213793 is an FDA 510(k) clearance for the EMPOWR Revision Knee. 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 April 1, 2022 after a review of 116 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

Submission Details

510(k) Number K213793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2021
Decision Date April 01, 2022
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 771
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K213793.
MyKnee R Pin Positioners
K220705 · Medacta International S.A. · May 2022
Legion Inserts with JRNY Lock
K220896 · Smith & Nephew, Inc. · Apr 2022
World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
K220737 · Signature Orthopaedics Pty, Ltd. · Apr 2022
b-ONE MOBIO Total Knee System
K213673 · B-One Ortho, Corp. · Jan 2022
Physica system
K213381 · Lima Corporate S.P.A. · Dec 2021
LOSPA TKR System
K212034 · Corentec Co., Ltd. · Dec 2021