510(k) Report

Devices descending from K060969

10 later devices reach Polyax Locked Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—