Cleared Traditional

K945613 - DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT

K945613 is an FDA 510(k) clearance for DURACON(TM) UNICOMPARTMENTAL FEMORAL CO..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K945613 · Howmedica Corp. · Orthopedic device
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Mar 1995
Decision
111d
Days
Class 2
Risk

K945613 is an FDA 510(k) clearance for the DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT. 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 6, 1995 after a review of 111 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

FDA 510(k) Submission Details - K945613

510(k) Number K945613 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 15, 1994
Decision Date March 06, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K945613.
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K952068 · Zimmer, Inc. · Sep 1995
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
K942263 · Zimmer, Inc. · Jul 1995
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · Depuy, Inc. · Oct 1994
P.C.A. MODULAR KNEE SYSTEM
K931214 · Howmedica Corp. · Feb 1994
DURACON UNICOMPARTMENTAL KNEE SYSTEM
K926231 · Howmedica Corp. · Mar 1993