510(k) Report

Devices descending from K924138

581 later devices reach Osteomed M3 System (SBF System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242861TrueLok ElevateOrthofix Srl20243—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+9K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—