Cleared Special

NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS (K052879) - FDA 510(k) Clearance

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

K052879 · Zimmer, Inc. · Orthopedic device
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Nov 2005
Decision
41d
Days
Class 2
Risk

K052879 is an FDA 510(k) clearance for the NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS. 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 22, 2005 after a review of 41 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 Zimmer, Inc. devices

Submission Details

510(k) Number K052879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2005
Decision Date November 22, 2005
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K052879.
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
K060370 · Zimmer, Inc. · Apr 2006
DEPUY PFC SIGMA KNEE PROSTHESIS
K060515 · DePuy Orthopaedics, Inc. · Mar 2006
COLUMBUS (CR) TOTAL KNEE SYSTEM
K053390 · Aesculap, Inc. · Feb 2006
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977 · Howmedica Osteonics Corp. · Oct 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229 · Smith & Nephew, Inc. · Jul 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210 · Biomet, Inc. · Jul 2005