510(k) Report

Devices descending from K912598

27 later devices reach Ace Cortical Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970549Titanium Alloy Bone ScrewsAesculap, Inc.199726—
+2K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+2K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+2K994382Nonlinear Taper Lag ScrewTheken Surgical20000—
+3K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+3K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K170697GBR systemSurgident20182—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+4K143730GBR SystemJeil Medical Corporation20152—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—