Cleared Traditional

K902365 - MODULAR UNIPOLAR SYSTEM

K902365 is the FDA 510(k) clearance for MODULAR UNIPOLAR SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K902365 · Howmedica Corp. · Orthopedic device
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Jan 1991
Decision
226d
Days
Class 2
Risk

K902365 is an FDA 510(k) clearance for the MODULAR UNIPOLAR SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on January 11, 1991 after a review of 226 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K902365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date January 11, 1991
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
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 73
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K902365.
OMNIFIT M-HA HIP STEM SERIES
K920231 · Stryker Corp. · Jun 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · Orthomet, Inc. · Mar 1992
MTS FEMORAL HIP SYSTEM
K903877 · 3M Company · Jan 1991
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990
THOMPSON TYPE HIS PROSTHESIS
K903240 · Onyx Medical Corp. · Jul 1990
AUSTIN MOORE TYPE HIP PROSTHESIS
K903241 · Onyx Medical Corp. · Jul 1990