Cleared Traditional

K952830 - DARWIN KNEE SYSTEM (TC3)

K952830 is the FDA 510(k) clearance for DARWIN KNEE SYSTEM (TC3) by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K952830 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Jan 1996
Decision
212d
Days
Class 2
Risk

K952830 is an FDA 510(k) clearance for the DARWIN KNEE SYSTEM (TC3). 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 January 18, 1996 after a review of 212 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 K952830 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 20, 1995
Decision Date January 18, 1996
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K952830.
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
K954909 · Smith & Nephew Richards, Inc. · Jan 1996
ULTRACK TOTAL KNEE SYSTEM
K953439 · Wrightmedicaltechnologyinc · Jan 1996
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
K954684 · Depuy, Inc. · Jan 1996
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · Howmedica Corp. · Nov 1995
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · Howmedica Corp. · Sep 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · Smith & Nephew Richards, Inc. · Sep 1995