510(k) Report

Devices descending from K933948

317 later devices reach Acufex Endobutton System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—