510(k) Report

Devices descending from K082022

13 later devices reach Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.2011121
+2K153776Optetrak One Logic Femoral ComponentsExactech, Inc.20164—
+2K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.201523
+2K132161Optetrak Logic PS 17MM & 19MM Thick Inserts, Optetrak Logic PSC 17MM & 19MM Thick InsertsExactech, Inc.201331
+2K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.20137—
+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—
+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—
+4K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—