510(k) Report

Devices descending from K090112

20 later devices reach Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233958hekaDrillZethon, Ltd.20240—
+1K193630hekaDrillZethon, Ltd.20210—
+1K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+1K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions201710—
+1K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+2K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+2K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+2K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+3K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+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—
+4K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+5K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+5K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—