# K240568: DuraPro™ Oscillating System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 29, 2024 after 60 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K040583 (2004). 732 ancestors in all.
No later device cites it as a predicate yet.
5 of 733 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233638: VERZA™ High Speed Drills, Globus Medical, Inc. (2024) Summary page 5.
- K183644: Stealth-Midas MR8 System, Medtronic Powered Surgical Solutions (2019) Summary page 5.
- K190653: ExcelsiusGPS, Globus Medical, Inc. (2019) Summary page 5.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 5.
- K211616: ExcelsiusHub, Globus Medical, Inc. (2021) Summary page 5.

## Indications for use
The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures. ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

Source page: https://510kreport.com/device/K240568
Methodology: https://510kreport.com/methodology