510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K203011Monster Screw SystemParagon 28, Inc.20206—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K191241AutoStrutOrthospin20194—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K180500VariAx 2 SystemStryker GmbH201812—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+6K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K153378Monster BITE Screw SystemParagon 28201522—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K251555Ultra™ Compression Screw SystemPace Surgical20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—