510(k) Report

Devices descending from K093360

15 later devices reach Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153776Optetrak One Logic Femoral ComponentsExactech, Inc.20164—
+1K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.201523
+1K150890Exactech Optetrak Logic CCExactech, Inc.201534
+1K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc.201331
+1K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.20137—
+1K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.2011121
+1K110547Optertrak Logic PSC Tibial InsertExactech Sarasota20114—
+2K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+2K171045Exactech® Truliant™ Line ExtensionsExactech, Inc.201712
+2K170240Truliant Femoral ComponentsExactech, Inc.20172—
+2K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+2K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+2K123342Optetrak Logic CRC Tibial InsertExactech, Inc.20134—
+2K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc.201211—
+3K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—