510(k) Report

Devices descending from K974876

419 later devices reach Bionx Distal Radius Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230212OrthoButton ALRiverpoint Medical, LLC20232—
+10K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+10K202399OrthoButton FLRiverpoint Medical20201—
+10K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+10K180500VariAx 2 SystemStryker GmbH201812—
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+11K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+11K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+11K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+11K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+11K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+11K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+12K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+13K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+13K233919VariAx 2 Distal Radius SystemStryker GmbH20242—