Cleared Traditional

K904119 - PROFILE COLLARED HIP PROSTHESIS

K904119 is the FDA 510(k) clearance for PROFILE COLLARED HIP PROSTHESIS by Depuy, Inc.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K904119 · Depuy, Inc. · Orthopedic device
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Oct 1990
Decision
35d
Days
Class 2
Risk

K904119 is an FDA 510(k) clearance for the PROFILE COLLARED HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 11, 1990 after a review of 35 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 Depuy, Inc. devices

Submission Details

510(k) Number K904119 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 06, 1990
Decision Date October 11, 1990
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K904119.
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · Orthomet, Inc. · Mar 1992
MTS FEMORAL HIP SYSTEM
K903877 · 3M Company · Jan 1991
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K903884 · Kinamed, Inc. · Sep 1990
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K903885 · Kinamed, Inc. · Sep 1990
THOMPSON TYPE HIS PROSTHESIS
K903240 · Onyx Medical Corp. · Jul 1990