510(k) Report

Devices descending from K080358

22 later devices reach Plla, HA Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+1K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+2K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+2K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+2K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+2K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+2K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+2K151220Dunamis Interference ScrewDunamis, LLC20150—
+2K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+2K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+2K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+2K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+3K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+3K203335MectaScrew ExtensionMedacta International S.A.20220—
+3K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+3K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+4K192810Apollo Suture Anchor SystemValeris Medical20201—
+4K152255BoneCam Suture AnchorsValeris Medical20151—
+5K193108Bonecam Suture AnchorValeris Medical, Inc.20200—