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FDA 510(k)

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

K-Number: K252989 · 2026-02-20

ApplicantPoint Robotics MedTech, Inc.
Decision Date2026-02-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is a medical device manufactured by Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2026-02-20 under approval number K252989. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by Point Robotics MedTech, Inc.. The 510(k) number is K252989.

When was “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set approved by the FDA?

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set received FDA 510(k) clearance on 2026-02-20, under approval number K252989.

What company makes “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is manufactured by Point Robotics MedTech, Inc..

What is the FDA product code for “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

The FDA product code for “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Point Robotics MedTech, Inc.

K220241“POINT” Kinguide Robotic-Assisted Surgical System K230087“POINT” Kinguide Agile Hybrid Navigation System K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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