Cleared Traditional

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (K900638) - FDA 510(k) Clearance

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

K900638 · Johnson & Johnson International · Orthopedic device
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Apr 1990
Decision
80d
Days
Class 2
Risk

K900638 is an FDA 510(k) clearance for the P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Johnson & Johnson International (Braintree, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson International devices

Submission Details

510(k) Number K900638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date April 30, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 50
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K900638.
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · Howmedica Corp. · May 1990
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · Depuy, Inc. · May 1989
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K872776 · Depuy, Inc. · Aug 1987