510(k) Report

Devices descending from K012001

337 later devices reach Smartscrew through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+9K253538TeKBrace Knotless AnchorTheramicro20260—
+9K253695LigaMendRiverpoint Medical, LLC20260—
+9K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+9K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+9K243988RootMend MRRRiverpoint Medical, LLC20250—
+9K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+9K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+9K240194ProCinch, QuadCinchRiverpoint Medical20240—
+9K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+9K233552IDEAL ZiploopRiverpoint Medical20230—
+9K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+9K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+9K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+9K230212OrthoButton ALRiverpoint Medical, LLC20232—
+9K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+9K202399OrthoButton FLRiverpoint Medical20201—
+9K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+9K180500VariAx 2 SystemStryker GmbH201812—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+10K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+10K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+10K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+10K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+10K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+10K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+10K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+10K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+11K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+11K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+11K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+12K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+12K233919VariAx 2 Distal Radius SystemStryker GmbH20242—