510(k) Report

Devices descending from K000080

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K191241AutoStrutOrthospin20194—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+5K173746Activmotion RangeNewclip Technics20181—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—