Cleared Traditional

K951185 - NEXGEN COMPLETE KNEE SOLUTION 9MM ARTIC...

K951185 is an FDA 510(k) clearance for NEXGEN COMPLETE KNEE SOLUTION 9MM ARTIC..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 365-day FDA review.

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

FDA 510(k) Submission Details - K951185

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.

JWH Device Classification - Class 2, Special Controls

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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K951185.
NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
K934695 · Intermedics Orthopedics · May 1996
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
K960279 · Zimmer, Inc. · Apr 1996
APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
K960535 · Intermedics Orthopedics · 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