Cleared Traditional

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

K252755 · Point Robotics MedTech, Inc. · Orthopedic

Jan 2026

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K252755 is an FDA 510(k) clearance for the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System, 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 January 23, 2026, 147 days after receiving the submission on August 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252755 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2025
Decision Date	January 23, 2026
Days to Decision	147 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.