510(k) Report

Devices descending from K953818

50 later devices reach Dall-Miles Suture/Beaded Cable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20208—
+1K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.199728—
+1K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.199633—
+1K961283Dall-Miles Homogenous Vitallium CableHowmedica Corp.199628—
+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—
+2K172350AxSOS 3 TiStryker GmbH201717—
+2K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310—
+2K023564Osse-LignOsseus, LLC20030—
+2K984432Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp.19992—
+2K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC19982—
+2K982545BMP Cable SystemBiomet, Inc.1998171
+2K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces19973—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K233949ACCORD Cable SystemSmith & Nephew, Inc.20240—
+3K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew20231—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20200—
+3K181091AxSOS 3 TiStryker GmbH201811—
+3K173910Impress SFS SystemCable Fix Medical, LLC20180—
+3K133354Peri-Prosthetic Cable SystemBiomet, Inc.20140—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K072250Supercable Grip and Plate SystemKinamed, Inc.200711
+3K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L.20061—
+3K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051—
+3K024022Osteo-Cable SleeveBiomet, Inc.20030—
+3K013657Modification to: Biomet Humeral Cable PlatesBiomet Orthopedics, Inc.20010—
+4K261038Xpert PFPNewclip Technics20260—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K233017TM Plating SystemTyber Medical, LLC20231—