510(k) Report

Devices descending from K100048

114 later devices reach E1 Antioxidant Infused Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—