Cleared Traditional

NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE (K951185) - FDA 510(k) Clearance

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

K951185 · Zimmer, Inc. · Orthopedic device
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Mar 1996
Decision
365d
Days
Class 2
Risk

K951185 is an FDA 510(k) clearance for the NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE. 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 March 15, 1996 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K951185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date March 15, 1996
Days to Decision 365 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
243d slower than avg
Panel avg: 122d · This submission: 365d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K951185.
DURACON INSET PATELLA WITH CENTRAL PEG
K961482 · Howmedica Corp. · Jul 1996
DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
K961379 · Depuy, Inc. · Jun 1996
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
K960279 · Zimmer, Inc. · Apr 1996
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · Biomet, Inc. · Mar 1996
COORDINATE REVISION KNEE SYSTEM
K955884 · Depuy, Inc. · Mar 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · Exactech, Inc. · Feb 1996