510(k) Report

Devices descending from K122211

20 later devices reach Synthes Navigable Pedicle Preparation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+1K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+1K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+1K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+1K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+1K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+1K170937VIPER PRIME navigated inserterMedos International SARL20176—
+1K140927Universal Navigation InstrumentsMedos International SARL20141—
+2K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+2K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+2K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+2K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+3K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—