510(k) Report

Devices descending from K032224

16 later devices reach Biorci Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+1K193497Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd.202118
+1K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+1K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+1K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC20097—
+1K040542Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc.20043—
+2K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+2K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited20210—
+2K202662Parcus Titanium Interference ScrewsParcus Medical, LLC20210—
+2K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+2K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+3K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+3K170877Parcus SLiK Fix ScrewParcus Medical20171—
+3K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+4K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+4K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—