510(k) Report

Devices descending from K924018

580 later devices reach M3 Lag Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K213214Xpert WristNewclip Technics20210—
+7K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K203381Dynanail Mini HybridMedShape, Inc.202141
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+7K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K193366T2 ICFStryker GmbH20201—
+7K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173641Activ AnkleNewclip Technics20183—
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+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—
+8K262344Large Compression ScrewsTriMed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K261241TriMed Compression ScrewsTriMed, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+8K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+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—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+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—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+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—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K242861TrueLok ElevateOrthofix Srl20243—
+9K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+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—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+11K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+11K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—