Cleared Traditional

K920231 - OMNIFIT M-HA HIP STEM SERIES

K920231 is the FDA 510(k) clearance for OMNIFIT M-HA HIP STEM SERIES by Stryker Corp.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K920231 · Stryker Corp. · Orthopedic device
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Jun 1992
Decision
143d
Days
Class 2
Risk

K920231 is an FDA 510(k) clearance for the OMNIFIT M-HA HIP STEM SERIES. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on June 8, 1992 after a review of 143 days - within the typical 510(k) review window.

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 Stryker Corp. devices

Submission Details

510(k) Number K920231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date June 08, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 122d · This submission: 143d
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 75
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K920231.
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120 · Depuy, Inc. · Mar 1993
OSTRONCS HEMI-HIP STEM SERIES
K922146 · Osteonics Corp. · Aug 1992
OMNIFLEX M-HA HIP STEM SERIES
K920193 · 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
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991