510(k) Report

Devices descending from K150216

149 later devices reach Synergy Cranial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K212397StealthStation S8 Cranial v2.0Medtronic Navigation20214Class I
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K203005Mazor XMazor Robotics, Ltd.2020141
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+6K241481xvision Spine SystemAugmedics, Ltd.20243—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K232176STELLAR KneePolarisar, Inc.20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20231—
+6K230789Knee+Pixee Medical20235—
+6K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+6K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250255xvision Spine systemAugmedics, Ltd.20252—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241870OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20240—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K233899Knee+Pixee Medical20244—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251639xvision Spine systemAugmedics, Ltd.20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243975Knee+Pixee Medical20253—
+9K261854xvision Spine systemAugmedics, Ltd.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253805Knee+Pixee Medical S.A.S.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—