# K220241: “POINT” Kinguide Robotic-Assisted Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Point Robotics MedTech, Inc.
- Decided: Aug 9, 2022 after 193 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: 12 generations back to K862807 (1986). 74 ancestors in all.
4 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)
- 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.
- K160713: Stealth-Midas System, Medtronic Powered Surgical Solutions (2016) Summary page 5.

## Most influential descendants
- K230087: “POINT” Kinguide Agile Hybrid Navigation System (2023), 3 descendants of its own
- 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 Robotic-Assisted Surgical 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 medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).

Source page: https://510kreport.com/device/K220241
Methodology: https://510kreport.com/methodology