# Point Robotics MedTech, Inc.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 5 (2022–2026): 5 510(k) clearances
- Product codes: OLO (5)
- 510(k) review time since 2016: median 155 days, against 90 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Navigation, Inc.: 8 (https://510kreport.com/company/medtronic-navigation)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Medtronic Powered Surgical Solutions: 1 (https://510kreport.com/company/medtronic-powered-surgical-solutions)

## Its most-cited devices
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (2024), cited by 2
- K220241: “POINT” Kinguide Robotic-Assisted Surgical System (2022), cited by 1
- K230087: “POINT” Kinguide Agile Hybrid Navigation System (2023), cited by 1

## Recent decisions
- K252989: “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (Feb 20, 2026)
- K252755: POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (Jan 23, 2026)
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (Jul 24, 2024)
- K230087: “POINT” Kinguide Agile Hybrid Navigation System (Jul 17, 2023)
- K220241: “POINT” Kinguide Robotic-Assisted Surgical System (Aug 9, 2022)

Source page: https://510kreport.com/company/point-robotics-medtech