510(k) Report

Devices descending from K031050

314 later devices reach PCW Percutaneous Compression Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+5K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+5K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+6K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112