Cleared Traditional

K931466 - PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI

K931466 is an FDA 510(k) clearance for PFC MODULAR TOTAL KNEE SYSTEM, manufactured by Johnson & Johnson Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 622-day FDA review.

K931466 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
622d
Days
Class 2
Risk

K931466 is an FDA 510(k) clearance for the PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Johnson & Johnson Orthopaedics, Inc. (Raynham, US). The FDA issued a Cleared decision on December 6, 1994 after a review of 622 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Johnson & Johnson Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K931466

510(k) Number K931466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date December 06, 1994
Days to Decision 622 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
500d slower than avg
Panel avg: 122d · This submission: 622d
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 847
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K931466.
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
K944845 · Wrightmedicaltechnologyinc · Dec 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · Exactech, Inc. · Dec 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · Osteonics Corp. · Dec 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · Howmedica Corp. · Nov 1994
FOUNDATION POSTERIOR STABILIZED KNEE
K933539 · Encore Orthopedics, Inc. · Nov 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · Exactech, Inc. · Oct 1994