Cleared Traditional

POROUS COATED TITANIUM KNEE PROSTHES- (K843907) - FDA 510(k) Clearance

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

K843907 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Jan 1985
Decision
99d
Days
Class 2
Risk

K843907 is an FDA 510(k) clearance for the POROUS COATED TITANIUM KNEE PROSTHES-. 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 January 10, 1985 after a review of 99 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 K843907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1984
Decision Date January 10, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 K843907.
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · Osteonics Corp. · Mar 1986
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · Zimmer, Inc. · Dec 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · Howmedica Corp. · Jul 1985
ANTHRO-MODULAR TOTAL KNEE
K834432 · Zimmer, Inc. · Apr 1984
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · Zimmer, Inc. · Feb 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · Biomet, Inc. · Jan 1984