Cleared Traditional

K972401 - HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS

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

K972401 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K972401

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.

KRO Device Classification - Class 2, Special Controls

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 81
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