Cleared Traditional

CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION (K931752) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931752 · Corin Orthopedic Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
547d
Days
Class 2
Risk

K931752 is an FDA 510(k) clearance for the CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Corin Orthopedic Products (Tampa, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 547 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Corin Orthopedic Products devices

Submission Details

510(k) Number K931752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date October 07, 1994
Days to Decision 547 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
425d slower than avg
Panel avg: 122d · This submission: 547d
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 52
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K931752.
UNITRAX V40 MODULAR ADAPTOR
K954077 · Howmedica Corp. · Nov 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778 · Osteonics Corp. · Aug 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · Johnson & Johnson Professionals, Inc. · Jun 1995
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