510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+13K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+13K191009Arsenal Plating SystemTrilliant Surgical20192—
+13K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+13K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+13K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+13K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+13K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+14K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+14K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+14K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+14K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+14K252246Leforte MMF SystemJeil Medical Corporation20260—
+14K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+14K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+14K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+14K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+14K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+14K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+14K242861TrueLok ElevateOrthofix Srl20243—
+14K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+14K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+14K241846E3D™-C Interbody SystemEvolution Spine20246—
+14K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+14K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+14K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+14K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+14K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+14K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+14K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+14K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+14K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+14K192592Axis Plating SystemExtremity Medical, LLC20190—
+14K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+14K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+15K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+15K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+15K262094E3D™-C Interbody SystemEvolution Spine20260—
+15K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+15K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+15K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+15K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+15K260038E3D™-C Interbody SystemEvolution Spine20261—
+15K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+15K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+15K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+15K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+15K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+15K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+16K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+16K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+16K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+16K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+16K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+17K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+18K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—