510(k) Report

Devices descending from K984550

310 later devices reach Pre-Threaded Endobutton through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—