# K181596: Spine Wave Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Oct 24, 2018 after 128 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: 11 generations back to K862807 (1986). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps, Medtronic Navigation, Inc. (2013) Summary page 4.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K192526: Spine Wave Navigated Instruments (2019), 0 descendants of its own

## 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, or Proficient® Posterior Cervical 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/K181596
Methodology: https://510kreport.com/methodology