Cleared Traditional

K972401 - HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS (FDA 510(k) Clearance)

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

K972401 · Howmedica Corp. · Orthopedic device
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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
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 85
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