Cleared Traditional

K920193 - OMNIFLEX M-HA HIP STEM SERIES

K920193 is an FDA 510(k) clearance for OMNIFLEX M-HA HIP STEM SERIES, manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K920193 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
145d
Days
Class 2
Risk

K920193 is an FDA 510(k) clearance for the OMNIFLEX 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 145 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

FDA 510(k) Submission Details - K920193

510(k) Number K920193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1992
Decision Date June 08, 1992
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 92
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K920193.
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120 · Depuy, Inc. · Mar 1993
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
K924379 · Johnson & Johnson Orthopaedics, Inc. · Feb 1993
OSTRONCS HEMI-HIP STEM SERIES
K922146 · Osteonics Corp. · Aug 1992
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