510(k) Report

Devices descending from K023294

220 later devices reach Bosworth Coraco-Clavicular Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K202399OrthoButton FLRiverpoint Medical20201—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K180500VariAx 2 SystemStryker GmbH201812—
+8K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+9K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+10K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+10K233919VariAx 2 Distal Radius SystemStryker GmbH20242—