# K231494: CoreLink Robotic Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Oct 27, 2023 after 157 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). 785 ancestors in all.
No later device cites it as a predicate yet.
1 of 786 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.
- K221776: NextGen Pedicle Screw System, Corelink, LLC (2022) Summary page 5.
- K210539: CoreLink Midline Fixation System, Corelink, LLC (2021) Summary page 5.
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 5.

## Indications for use
CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Source page: https://510kreport.com/device/K231494
Methodology: https://510kreport.com/methodology