Cleared Traditional

DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED (K950010) - FDA 510(k) Clearance

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

K950010 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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May 1995
Decision
132d
Days
Class 2
Risk

K950010 is an FDA 510(k) clearance for the DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raritan, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 132 days - within the typical 510(k) review window.

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 K950010 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 03, 1995
Decision Date May 15, 1995
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 K950010.
DEPUY AMK CO-CR FINNED TIBIAL TRAY
K951027 · Depuy, Inc. · Jul 1995
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · Zimmer, Inc. · Jul 1995
DURACON RECESSED PATELLA
K951655 · Howmedica Corp. · Jul 1995
DURACON STABILIZER FEMORAL COMPONENT AND INSERT
K932070 · Howmedica Corp. · Mar 1995
ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE
K945087 · Wrightmedicaltechnologyinc · Mar 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · Exactech, Inc. · Mar 1995