510(k) Report

Devices descending from K192217

11 later devices reach NCB Plating System Distal Femur and Proximal Tibia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+1K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+1K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—