Cleared Traditional

K945518 - P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED...

K945518 is the FDA 510(k) clearance for P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED... by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 485-day FDA review.

K945518 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
485d
Days
Class 2
Risk

K945518 is an FDA 510(k) clearance for the P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 485 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Professionals, Inc. devices

Submission Details

510(k) Number K945518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date March 08, 1996
Days to Decision 485 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
363d slower than avg
Panel avg: 122d · This submission: 485d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K945518.
ULTIMA FX FEMORAL HIP STEMS
K963885 · Johnson & Johnson Professionals, Inc. · Dec 1996
PRIMALOC CEMENTED HIP SYSTEM
K962448 · Ortho Development Corp. · Sep 1996
BI-LOC BIPOLAR CUP
K961793 · Ortho Development Corp. · Jul 1996
PRIMALOC CEMENTLESS HIP SYSTEM
K953977 · Ortho Development Corp. · Jan 1996
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · Depuy, Inc. · Sep 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · Encore Orthopedics, Inc. · Aug 1995