Cleared Special

OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS (K032606) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032606 · Exactech, Inc. · Orthopedic device
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Sep 2003
Decision
29d
Days
Class 2
Risk

K032606 is an FDA 510(k) clearance for the OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STA.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K032606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date September 23, 2003
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K032606.
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · Howmedica Osteonics Corp. · Dec 2003
SCORPIO NRG KNEE SYSTEM
K030978 · Howmedica Osteonics Corp. · Nov 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151 · Depuy, Inc. · Sep 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479 · Howmedica Osteonics Corp. · Sep 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · Howmedica Osteonics Corp. · Sep 2003
COLUMBUS (PS)
K030367 · Aesculap, Inc. · Aug 2003