510(k) Report

Devices descending from K003077

342 later devices reach Smartscrew Model 222006...227510 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K173135VariAx 2 SystemStryker GmbH201713—
+7K171060OrthoButton ALRiverpoint Medical20178—
+7K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+8K240194ProCinch, QuadCinchRiverpoint Medical20240—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K233552IDEAL ZiploopRiverpoint Medical20230—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K230212OrthoButton ALRiverpoint Medical, LLC20232—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K202399OrthoButton FLRiverpoint Medical20201—
+8K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+8K180500VariAx 2 SystemStryker GmbH201812—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+10K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+11K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+11K233919VariAx 2 Distal Radius SystemStryker GmbH20242—