510(k) Report

Devices descending from K032606

18 later devices reach Optetrak Total Knee System Asymmetric Femoral Components Size 6… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010152
+1K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…Exactech, Inc.2004173
+2K153776Optetrak One Logic Femoral ComponentsExactech, Inc.20164—
+2K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.201523
+2K150890Exactech Optetrak Logic CCExactech, Inc.201534
+2K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc.201331
+2K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.20137—
+2K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.2011121
+2K110547Optertrak Logic PSC Tibial InsertExactech Sarasota20114—
+2K071738Exactech Optetrak Proximal Tibial SpacerExactech, Inc.200702
+3K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+3K171045Exactech® Truliant™ Line ExtensionsExactech, Inc.201712
+3K170240Truliant Femoral ComponentsExactech, Inc.20172—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+3K123342Optetrak Logic CRC Tibial InsertExactech, Inc.20134—
+3K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc.201211—
+4K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—