510(k) Report

Devices descending from K971070

61 later devices reach Scarf Thread-Head (TM) Head Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070617Cannulated ScrewFournitures Hospitalieres Industrie20074—
+1K050924Merete Duothreadtm Bone ScrewMerete Medical GmbH20051—
+1K050346Stabilization ScrewNew Deal, S.A.2005554
+2K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+2K160617Large Screws RangeNewclip Technics20166—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K131920Stabilization ScrewIn2bones Sas2014183
+2K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+2K091798Merete Compression ScrewsMerete Medical GmbH200926—
+2K071639Qwix Positioning ScrewNewdeal Sas2007521
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K172596Large Screws RangeNewclip Technics20174—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K173641Activ AnkleNewclip Technics20183—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K261511Xpert AnkleNewclip Technics20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213214Xpert WristNewclip Technics20210—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—