# K211442: StealthStation Spinous Process Clamps

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: Jul 8, 2021 after 59 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: 13 generations back to K841189 (1984). 94 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 4.

## Most influential descendants
- K242464: Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (2025), 1 descendant of its own
- K254165: Infinity™ OCT System (2026), 0 descendants of its own

## Indications for use
The 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. When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.

Source page: https://510kreport.com/device/K211442
Methodology: https://510kreport.com/methodology