# K162921: Navigated Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Mar 13, 2017 after 146 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: 15 generations back to K853033 (1985). 259 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 265 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION 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 USA, Inc. (2016) Summary page 4.
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 4.

## Most influential descendants
- K172115: Navigated Instrument System (2018), 4 descendants of its own
- K191722: Vital Navigation System (2019), 2 descendants of its own
- K233443: Vital™ Navigation System (2023), 0 descendants of its own
- K213491: Universal Pilot Guidance Instrument System (2022), 0 descendants of its own
- K213720: Vital Navigation System (2022), 0 descendants of its own

## Indications for use
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the BrainLab Vector Vision system and the Medtronic 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 skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Source page: https://510kreport.com/device/K162921
Methodology: https://510kreport.com/methodology