# K252989: “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set

- Pathway: 510(k) (Traditional)
- Applicant: Point Robotics MedTech, Inc.
- Decided: Feb 20, 2026 after 155 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: 15 generations back to K862807 (1986). 80 ancestors in all.
No later device cites it as a predicate yet.
3 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000), Point Robotics MedTech, Inc. (2024) Summary page 6.
- K201189: Stealthstation S8 Spine Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 6.
- K201327: NavLock Trackers, Medtronic Navigation (2020) Summary page 6.

## Indications for use
“POINT” Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

Source page: https://510kreport.com/device/K252989
Methodology: https://510kreport.com/methodology