# K230880: CoreLink Navigation Instruments

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: May 2, 2023 after 33 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: 22 generations back to K003155 (2001). 668 ancestors in all.
No later device cites it as a predicate yet.
1 of 669 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220973: CoreLink Navigation Instruments, Corelink, LLC (2022) Summary page 4.
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems, Medtronic Sofamor Danek (2017) Summary page 5.
- K221776: NextGen Pedicle Screw System, Corelink, LLC (2022) Summary page 5.

## Indications for use
Corelink Navigation Instruments are intended to be used in the preparation and placement of Corelink screws 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 S8 (V1.2.0), 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/K230880
Methodology: https://510kreport.com/methodology