510(k) Report

Devices descending from K012465

310 later devices reach Multitak Splinter 3.0 MM Resorbable Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—