Cleared Traditional

K973121 - INTERAX TOTAL KNEE SYSTEM

K973121 is the FDA 510(k) clearance for INTERAX TOTAL KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973121 · Howmedica Corp. · Orthopedic device
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Nov 1997
Decision
90d
Days
Class 2
Risk

K973121 is an FDA 510(k) clearance for the INTERAX TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 18, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Howmedica Corp. devices

Submission Details

510(k) Number K973121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date November 18, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 768
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K973121.
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
K973412 · Sulzer Orthopedics, Inc. · Dec 1997
NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT
K972270 · Zimmer, Inc. · Nov 1997
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
K973164 · Howmedica Corp. · Nov 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K972863 · Howmedica Corp. · Oct 1997
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
K972864 · Howmedica Corp. · Oct 1997
DURACON CONVERSION METAL BACKED PATELLA
K972752 · Howmedica Corp. · Oct 1997