Cleared Traditional

K926231 - DURACON UNICOMPARTMENTAL KNEE SYSTEM

K926231 is the FDA 510(k) clearance for DURACON UNICOMPARTMENTAL KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K926231 · Howmedica Corp. · Orthopedic device
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Mar 1993
Decision
109d
Days
Class 2
Risk

K926231 is an FDA 510(k) clearance for the DURACON UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 30, 1993 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 K926231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1992
Decision Date March 30, 1993
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 94
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K926231.
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
K945613 · Howmedica Corp. · Mar 1995
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · Depuy, Inc. · Oct 1994
P.C.A. MODULAR KNEE SYSTEM
K931214 · Howmedica Corp. · Feb 1994
KEANE UNI KNEE SYSTEM WITH POROCOAT
K921232 · Depuy, Inc. · Jun 1992
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
K915240 · Intermedics Orthopedics · Jan 1992
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
K912735 · Smith & Nephew Richards, Inc. · Dec 1991