510(k) Report

Devices descending from K030198

678 later devices reach Hand Innovations, Inc. Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+10K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+10K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+10K231860TDM Screw SystemTdm Co., Ltd.20240—
+10K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+10K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+10K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+10K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+10K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+10K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+10K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+10K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+10K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+10K191009Arsenal Plating SystemTrilliant Surgical20192—
+10K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+10K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+10K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+10K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+10K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+11K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K252246Leforte MMF SystemJeil Medical Corporation20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+11K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242861TrueLok ElevateOrthofix Srl20243—
+11K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+11K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+11K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+11K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+11K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+11K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+11K192592Axis Plating SystemExtremity Medical, LLC20190—
+11K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+11K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+12K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+12K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+12K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+12K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+12K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+13K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+13K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+13K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+14K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+15K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—