510(k) Report

Devices descending from K052776

217 later devices reach Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180500VariAx 2 SystemStryker GmbH201812—
+7K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+8K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+9K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+9K233919VariAx 2 Distal Radius SystemStryker GmbH20242—