# K200095: Streamline Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
- Decided: Jun 26, 2020 after 162 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K862807 (1986). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Recalls of this device
- Sep 24, 2020 · Class II · Z-0300-2021: The Streamline Navigation System taps have experienced binding with other devices.
- Sep 24, 2020 · Class II · Z-0299-2021: The Streamline Navigation System taps have experienced binding with other devices.
- Sep 24, 2020 · Class II · Z-0322-2021: System does not include a drill guide.
- Sep 11, 2020 · Class II · Z-0320-2021: The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

## Indications for use
Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 of the anatomy.

Source page: https://510kreport.com/device/K200095
Methodology: https://510kreport.com/methodology