# K232572: Kalitec Navigated Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC Doing Business AS Kalitec Medical
- Decided: Dec 13, 2023 after 111 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: 10 generations back to K862807 (1986). 174 ancestors in all.
No later device cites it as a predicate yet.
0 of 175 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.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K140678: Cosmolock Pedicle Screw System, Kalitec Direct, LLC (2014) Summary page 4.
- K172808: CosmoLock Pedicle Screw System, Kalitec Direct, LLC (2017) Summary page 4.

## Indications for use
The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments 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 the Kalitec Navigated Instrument System instruments is limited to use only with Kalitec pedicle screw systems.

Source page: https://510kreport.com/device/K232572
Methodology: https://510kreport.com/methodology