# K191039: Navigated T2 STRATOSPHERE Inserters and Navigated Templates

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Aug 26, 2019 after 129 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 K003155 (2001). 215 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 4.
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System, Medtronic Sofamor Danek (2017) Summary page 4.
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 4.
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K192336: Navigated Anterolateral Disc Prep Instruments (2019), 17 descendants of its own
- K211441: Navigated Anterolateral Disc Prep Instruments (2021), 9 descendants of its own
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own
- K200719: NuVasive Navigation.S Instruments (2020), 4 descendants of its own
- K232345: ATEC Posterior Navigated Disc Prep Instruments (2023), 2 descendants of its own

## Indications for use
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 Stratosphere™ templates are intended to be used to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to be used to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant. Navigated instruments are specifically designed for use with the 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 a skull, a long bone, or 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/K191039
Methodology: https://510kreport.com/methodology