Cleared Traditional

?POINT? Kinguide Agile Hybrid Navigation System; DRF Accessories Set

K252989 · Point Robotics MedTech, Inc. · Orthopedic

Feb 2026

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K252989 is an FDA 510(k) clearance for the ?POINT? Kinguide Agile Hybrid Navigation System; DRF Accessories Set, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Point Robotics MedTech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on February 20, 2026, 155 days after receiving the submission on September 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252989 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2025
Decision Date	February 20, 2026
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.