510(k) Report

Devices descending from K990776

368 later devices reach Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+8K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+8K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+8K182677DynaNail MiniMedShape, Inc.20195—
+8K182989AURORA™ Screw SystemMiRus, LLC20180—
+8K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+8K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+8K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+8K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+8K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+8K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+8K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+8K150871ForeFoot STP SystemTornier, Inc.20150—
+8K151146N-Force Fixation SystemInnovision, Inc.20151—
+8K151418Monster Screw SystemParagon 28201527—
+8K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+8K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+8K142776Flow-ScrewFlow-Fx, LLC20151—
+8K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+8K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+9K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+9K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+9K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+9K203381Dynanail Mini HybridMedShape, Inc.202141
+9K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+9K193366T2 ICFStryker GmbH20201—
+9K173556Injection ScrewBiedermann Medtech, Inc.20180—
+9K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+9K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+9K153378Monster BITE Screw SystemParagon 28201522—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+10K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+10K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+10K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+10K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+10K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+11K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K240487EVOS Patella PlatesSmith & Nephew20240—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—