# K212825: CoreLink Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Oct 13, 2021 after 40 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: 18 generations back to K040583 (2004). 224 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182731: Corelink Navigation Instruments, Corelink, LLC (2019) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- 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.

## Most influential descendants
- K220973: CoreLink Navigation Instruments (2022), 1 descendant of its own
- K232116: CoreLink Navigation Instruments (2023), 0 descendants of its own
- K230880: CoreLink Navigation Instruments (2023), 0 descendants of its own
- K214059: CoreLink Navigation Instruments (2022), 0 descendants of its own

## Indications for use
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) 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 (V1.2.20), 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/K212825
Methodology: https://510kreport.com/methodology