Cleared Traditional

PROFILE COLLARED HIP PROSTHESIS (K904119) - FDA 510(k) Clearance

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

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 49
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K904119.
OSTRONCS HEMI-HIP STEM SERIES
K922146 · Osteonics Corp. · Aug 1992
MTS FEMORAL HIP SYSTEM
K903877 · 3M Company · Jan 1991
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991
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