Cleared Traditional

DARWIN KNEE SYSTEM (K943462) - FDA 510(k) Clearance

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

K943462 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Dec 1994
Decision
156d
Days
Class 2
Risk

K943462 is an FDA 510(k) clearance for the DARWIN KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 156 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K943462 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 18, 1994
Decision Date December 21, 1994
Days to Decision 156 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 122d · This submission: 156d
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 K943462.
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY
K943299 · Depuy, Inc. · Jan 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610 · Exactech, Inc. · Jan 1995
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
K941755 · Wrightmedicaltechnologyinc · Jan 1995
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
K944285 · Osteonics Corp. · Dec 1994
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
K944845 · Wrightmedicaltechnologyinc · Dec 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · Exactech, Inc. · Dec 1994