510(k) Report

Devices descending from K971069

61 later devices reach Twist-Off (TM) Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+1K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+1K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K170012Foot and Hand MotionNewclip Technics20170—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131311Arix Foot SystemJeil Medical Corporation20139—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+3K170697GBR systemSurgident20182—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K161864ARIX Foot SystemJeil Medical Corporation20165—
+3K143730GBR SystemJeil Medical Corporation20152—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—