Cleared Traditional

K972401 - HOWMEDICA MODULAR REPLACEMENT SYSTEM - ...

K972401 is the FDA 510(k) clearance for HOWMEDICA MODULAR REPLACEMENT SYSTEM - ... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K972401 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
382d
Days
Class 2
Risk

K972401 is an FDA 510(k) clearance for the HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K972401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date July 13, 1998
Days to Decision 382 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
260d slower than avg
Panel avg: 122d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 69
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K972401.
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · Howmedica Osteonics Corp. · Jun 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · Howmedica Osteonics Corp. · Mar 2000
HINGED KNEE
K982160 · Encore Orthopedics, Inc. · Mar 1999
FINN KNEE SYSTEM
K945028 · Biomet, Inc. · Feb 1996
FINN KNEE PROSTHESIS
K910877 · Biomet, Inc. · Jul 1991
DCW MODULAR DISTAL FEMORAL SYSTEM
K910596 · Dow Corning Wright · May 1991