Cleared Traditional

?POINT? Kinguide Agile Hybrid Navigation System (PSHF01-000)

K241130 · Point Robotics MedTech, Inc. · Orthopedic

Jul 2024

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K241130 is an FDA 510(k) clearance for the ?POINT? Kinguide Agile Hybrid Navigation System (PSHF01-000), 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 July 24, 2024, 91 days after receiving the submission on April 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K241130 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2024
Decision Date	July 24, 2024
Days to Decision	91 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.