# K243814: NuVasive Pulse System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jan 10, 2025 after 30 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: 21 generations back to K003155 (2001). 762 ancestors in all.
No later device cites it as a predicate yet.
3 of 763 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210574: NuVasive Pulse System, Nu Vasive, Incorporated (2021) 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.

## Indications for use
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: - Pedicle Screw Placement (cervical, thoracic, lumbar) - Iliosacral screw placement

Source page: https://510kreport.com/device/K243814
Methodology: https://510kreport.com/methodology