510(k) Report

Devices descending from K953714

420 later devices reach Zimmer Reconstruction System Symphyseal Bone Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+11K230212OrthoButton ALRiverpoint Medical, LLC20232—
+11K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+11K202399OrthoButton FLRiverpoint Medical20201—
+11K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+11K180500VariAx 2 SystemStryker GmbH201812—
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+12K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+12K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+12K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+12K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+12K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+12K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+12K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+12K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+13K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+13K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+13K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+14K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+14K233919VariAx 2 Distal Radius SystemStryker GmbH20242—