510(k) Report

Devices descending from K131670

5 later devices reach Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc.201845
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—