# K192526: Spine Wave Navigated Instruments

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Oct 10, 2019 after 27 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: 12 generations back to K862807 (1986). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181596: Spine Wave Navigated Instruments, Spine Wave, Inc. (2018) Summary page 4.

## Indications for use
The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

Source page: https://510kreport.com/device/K192526
Methodology: https://510kreport.com/methodology