Cleared Traditional

K902365 - MODULAR UNIPOLAR SYSTEM

K902365 is an FDA 510(k) clearance for MODULAR UNIPOLAR SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K902365

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.

KWL Device Classification - Class 2, Special Controls

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 91
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
THOMPSON TYPE HIP PROSTHESIS
K905334 · O'Tec Corp. · Dec 1990
AUSTIN MOORE TYPE HIP PROTHESIS
K905349 · O'Tec Corp. · Dec 1990
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990