# K213491: Universal Pilot Guidance Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: May 12, 2022 after 192 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: 17 generations back to K040583 (2004). 387 ancestors in all.
No later device cites it as a predicate yet.
1 of 388 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172115: Navigated Instrument System, Orthofix, Inc. (2018) Summary page 4.
- 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.

## Indications for use
The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is specifically designed for use with the Medtronic StealthStation System, which is 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 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/K213491
Methodology: https://510kreport.com/methodology