# K252755: POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Point Robotics MedTech, Inc.
- Decided: Jan 23, 2026 after 147 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). 90 ancestors in all.
No later device cites it as a predicate yet.
4 of 91 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.
- K202320: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System, Brainlab AG (2020) Summary page 6.

## Indications for use
“POINT” Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible “POINT” Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. “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/K252755
Methodology: https://510kreport.com/methodology