Cleared Traditional

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (K230169) - FDA 510(k) Clearance

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

K230169 · Encore Medical, L.P Dba Enovis · Orthopedic device
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Apr 2023
Decision
76d
Days
Class 2
Risk

K230169 is an FDA 510(k) clearance for the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ 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 Dba Enovis (Austin, US). The FDA issued a Cleared decision on April 6, 2023 after a review of 76 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 K230169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2023
Decision Date April 06, 2023
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 542
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K230169.
Klassic Knee Revision System
K230537 · Total Joint Othopedics, Inc. · May 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
K230653 · Smith & Nephew, Inc. · May 2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
K230844 · Conformis, Inc. · Apr 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · Smith & Nephew, Inc. · Mar 2023
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K230471 · Waldemar Link GmbH & Co. KG · Mar 2023
EMPOWR Stem Extender, 50mm
K230441 · Encore Medical, L.P Dba Enovis · Mar 2023