Cleared Traditional

K922146 - OSTRONCS HEMI-HIP STEM SERIES

K922146 is an FDA 510(k) clearance for OSTRONCS HEMI-HIP STEM SERIES, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K922146 · Osteonics Corp. · Orthopedic device
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Aug 1992
Decision
96d
Days
Class 2
Risk

K922146 is an FDA 510(k) clearance for the OSTRONCS HEMI-HIP STEM SERIES. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 96 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K922146

510(k) Number K922146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date August 11, 1992
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 K922146.
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
K924050 · Orthomet, Inc. · Aug 1993
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
OMNIFLEX M-HA HIP STEM SERIES
K920193 · Stryker Corp. · Jun 1992
OMNIFIT M-HA HIP STEM SERIES
K920231 · Stryker Corp. · Jun 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · Orthomet, Inc. · Mar 1992