Cleared Traditional

EMPOWR Revision Symmetric Knee Cones (K240324) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240324 · Encore Medical, L.P Dba Enovis · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
84d
Days
Class 2
Risk

K240324 is an FDA 510(k) clearance for the EMPOWR Revision Symmetric Knee Cones. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Encore Medical, L.P Dba Enovis (Austin, US). The FDA issued a Cleared decision on April 26, 2024 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Encore Medical, L.P Dba Enovis devices

Submission Details

510(k) Number K240324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date April 26, 2024
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 541
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K240324.
UNIKO PointCloud™ Knee Instruments
K240327 · Unik Orthopedics, Inc. · Jun 2024
Unity Knee PS-C Tibial Insert
K240875 · Corin U.S.A. Limited · Jun 2024
ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
K240669 · Globus Medical, Inc. · Jun 2024
KeYi Total Knee System
K230120 · Beijing Keyi Medical Device Technology Co., Ltd. · Apr 2024
XN Knee Prosthesis System
K232175 · Beijing Chunlizhengda Medical Instruments Co., Ltd. · Apr 2024
AMF TT Cones
K234011 · Lima Corporate S.P.A. · Jan 2024