510(k) Report

Devices descending from K961283

28 later devices reach Dall-Miles Homogenous Vitallium Cable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20208—
+1K172350AxSOS 3 TiStryker GmbH201717—
+1K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces19973—
+2K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+2K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+2K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+2K181091AxSOS 3 TiStryker GmbH201811—
+2K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC19982—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L.20061—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K233017TM Plating SystemTyber Medical, LLC20231—