# K223808: Zavation Navigation Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Jul 12, 2023 after 204 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: 18 generations back to K040583 (2004). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems, Medtronic Sofamor Danek (2017) Summary page 5.
- K153603: Alphatec Navigation Instruments, Alphatec Spine, Inc. (2016) Summary page 5.

## Indications for use
Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-LinkPC System. Please refer to the following Instructions for Use (IFU) and Surgical Techniques for complete system guides, descriptions, indications and warnings: • Zavation Spinal System • Zavation Z-LinkPC System • Medtronic StealthStation Navigation System

Source page: https://510kreport.com/device/K223808
Methodology: https://510kreport.com/methodology