Cleared Traditional

K021578 - NATURAL-KNEE II SYSTEM COCR TIBIAL BASE...

K021578 is an FDA 510(k) clearance for NATURAL-KNEE II SYSTEM COCR TIBIAL BASE..., manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021578 · Sulzer Orthopedics, Inc. · Orthopedic device
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Aug 2002
Decision
87d
Days
Class 2
Risk

K021578 is an FDA 510(k) clearance for the NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 9, 2002 after a review of 87 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K021578

510(k) Number K021578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2002
Decision Date August 09, 2002
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K021578.
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · Zimmer, Inc. · Oct 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · Smith & Nephew, Inc. · Aug 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · Biomet Orthopedics, Inc. · Aug 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · Aesculap, Inc. · Jul 2002
HLS NOETOS SYSTEM
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3D KNEE
K020114 · Encore Orthopedics, Inc. · Jul 2002