510(k) Report

Devices descending from K024060

857 later devices reach Modification to Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+7K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+7K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K151769Anchorage 2 CP SystemStryker GmbH20150—
+7K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K231860TDM Screw SystemTdm Co., Ltd.20240—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+8K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230026SqualeImplanet, S.A.20230—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+8K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+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—
+8K181091AxSOS 3 TiStryker GmbH201811—
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K242861TrueLok ElevateOrthofix Srl20243—
+9K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—