510(k) Report

Devices descending from K013248

116 later devices reach Synthes LCP Distal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—