510(k) Report

Devices descending from K020069

43 later devices reach Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193630hekaDrillZethon, Ltd.20210—
+1K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+1K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+1K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions201710—
+1K093361Synthes Air Pen Drive (Apd) SystemSynthes (Usa)20100—
+1K090112Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions200920—
+1K072315Midas Rex Curved BurMedtronic Powered Surgical Solutions200713—
+1K042974Medicon Vipair High Speed SystemMedicon EG20050—
+1K041754Stryker Maestro SystemStryker Corp.20048—
+1K032607Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp.20036—
+1K022942CraniocutAesculap, Inc.20020—
+2K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+2K233958hekaDrillZethon, Ltd.20240—
+2K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+2K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+2K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+2K150801Stryker Maestro Air MotorsStryker Corporation201511
+2K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp.201567
+2K062842Twist DrillWalter Lorenz Surgical, Inc.200651
+3K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+3K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation20221—
+3K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+3K213208Twist DrillsBiomet Microfixation20210—
+3K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+3K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+3K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+3K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker20195—
+3K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+3K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation201702
+3K070876Stryker Twist DrillsStryker Craniomaxillofacial20070—
+4K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+4K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation20220—
+5K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+5K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+5K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+5K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+6K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—