# K260011: Foundation Surgical Navigated Lateral Disc Prep Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Foundation Surgical Group, Inc.
- Decided: Apr 16, 2026 after 104 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: 31 generations back to K841189 (1984). 904 ancestors in all.
No later device cites it as a predicate yet.
5 of 905 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211441: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 6.
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 6.
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 6.

## Indications for use
Foundation Surgical Navigated Lateral Disc Prep Instruments are intended to be used during preparation of the intervertebral disc space during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Foundation Surgical Navigated Lateral Disc Prep Instruments are specifically designed for use with the Medtronic StealthStation™ S8 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments. The Navigated Trials are intended to be used to facilitate implant size selection of matching implants during spinal surgery.

Source page: https://510kreport.com/device/K260011
Methodology: https://510kreport.com/methodology