# Medtronic Powered Surgical Solutions

- Location (FDA's records): Fort Worth, TX
- FDA decisions: 9 (2007–2021): 9 510(k) clearances
- Product codes: HBC (3), HBB (2), HBE (2), OLO (2)
- 510(k) review time since 2016: median 72 days, against 120 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 23 (10 its own); citations of its devices by later devices: 22 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Midas Rex: 5 (https://510kreport.com/company/medtronic-midas-rex)
- Medtronic Xomed, Inc.: 3 (https://510kreport.com/company/medtronic-xomed)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Micro-Aire Surgical Instruments, Inc.: 1 (https://510kreport.com/company/micro-aire-surgical-instruments)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Sodemsystems: 1 (https://510kreport.com/company/sodemsystems)
- Medtronic Surgical Technologies: 1 (https://510kreport.com/company/medtronic-surgical-technologies)

## Firms that cite its devices most
- Zethon, Ltd.: 4 (https://510kreport.com/company/zethon)
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- Medtronic Powered Surgical Solutions (Mpss): 2 (https://510kreport.com/company/medtronic-powered-surgical-solutions-mpss)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Point Robotics MedTech, Inc.: 1 (https://510kreport.com/company/point-robotics-medtech)
- Guizhou Zirui Technology Co., Ltd.: 1 (https://510kreport.com/company/guizhou-zirui-technology)

## Its most-cited devices
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700 (2009), cited by 5
- K183644: Stealth-Midas MR8 System (2019), cited by 3
- K163565: MR8 Drill System (2017), cited by 3
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (2017), cited by 3
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (2017), cited by 2
- K072315: Midas Rex Curved Bur (2007), cited by 2

## Recent decisions
- K213454: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm (Nov 23, 2021)
- K183644: Stealth-Midas MR8 System (May 22, 2019)
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools (May 12, 2019)
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (May 15, 2017)
- K163565: MR8 Drill System (Mar 28, 2017)
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (Mar 23, 2017)
- K160713: Stealth-Midas System (May 26, 2016)
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700 (Mar 26, 2009)

Source page: https://510kreport.com/company/medtronic-powered-surgical-solutions