Cleared Special

EMPOWR Stem Extender, 50mm (K230441) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230441 · Encore Medical, L.P Dba Enovis · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
24d
Days
Class 2
Risk

K230441 is an FDA 510(k) clearance for the EMPOWR Stem Extender, 50mm. 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 March 17, 2023 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Medical, L.P Dba Enovis devices

Submission Details

510(k) Number K230441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date March 17, 2023
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 542
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K230441.
EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
K230169 · Encore Medical, L.P Dba Enovis · Apr 2023
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LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K230471 · Waldemar Link GmbH & Co. KG · Mar 2023
Persona™ Personalized Knee System
K230321 · Zimmer, Inc. · Mar 2023
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K222570 · Heraeus Medical GmbH · Feb 2023
REMEDY Stemmed Knee Spacer
K223650 · Osteoremedies, LLC · Jan 2023