Cleared Traditional

K152494 - Zimmer NexGen Complete Knee Solution Ti...

K152494 is the FDA 510(k) clearance for Zimmer NexGen Complete Knee Solution Ti... by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K152494 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
85d
Days
Class 2
Risk

K152494 is an FDA 510(k) clearance for the Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 25, 2015 after a review of 85 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 Zimmer, Inc. devices

Submission Details

510(k) Number K152494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date November 25, 2015
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 785
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K152494.
Optetrak Advanced Patella
K160484 · Exactech, Inc. · Mar 2016
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
K160025 · Conformis, Inc. · Mar 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217 · Conformis, Inc. · Jan 2016
Arthrex iBalance TKA System
K152382 · Arthrex, Inc. · Nov 2015
Physica PS Knee System
K152008 · Lima Corporate S.P.A. · Oct 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · Smith & Nephew, Inc. · Oct 2015