# K243514: Salvo® Robotic Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 3, 2025 after 141 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). 643 ancestors in all.
No later device cites it as a predicate yet.
1 of 644 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220862: E-GPS Navigated Instruments, Precision Spine, Inc. (2022) Summary page 5.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.

## Indications for use
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical’s ExcelsiusGPS® Robotic Navigation Platform, which 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.

Source page: https://510kreport.com/device/K243514
Methodology: https://510kreport.com/methodology