# K230087: “POINT” Kinguide Agile Hybrid Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Point Robotics MedTech, Inc.
- Decided: Jul 17, 2023 after 186 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: 13 generations back to K862807 (1986). 75 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220241: “POINT” Kinguide Robotic-Assisted Surgical System, Point Robotics MedTech, Inc. (2022) Summary page 5.
- K201189: Stealthstation S8 Spine Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 5.
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 5.

## Most influential descendants
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (2024), 2 descendants of its own
- K252989: “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (2026), 0 descendants of its own
- K252755: POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (2026), 0 descendants of its own

## 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 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

Source page: https://510kreport.com/device/K230087
Methodology: https://510kreport.com/methodology