510(k) Report

Devices descending from K051296

836 later devices reach Sijf Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+7K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+7K231860TDM Screw SystemTdm Co., Ltd.20240—
+7K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+7K230026SqualeImplanet, S.A.20230—
+7K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K181091AxSOS 3 TiStryker GmbH201811—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+8K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K242861TrueLok ElevateOrthofix Srl20243—
+8K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+8K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—