510(k) Report

Devices descending from K022325

521 later devices reach Normed Titanium Osteotomy Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+7K241539Activmotion SNewclip Technics20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+8K143092Tensyn PlugDallen Medical, Inc.20151—
+9K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+9K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+9K150359Tensyn PlugDallen Medical, Inc.20150—