510(k) Report

Devices descending from K043248

306 later devices reach Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+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—