Cleared Special

TMINI Miniature Robotic System

K242264 · THINK Surgical, Inc. · Orthopedic

Aug 2024

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K242264 is an FDA 510(k) clearance for the TMINI Miniature Robotic System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on August 23, 2024, 22 days after receiving the submission on August 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K242264 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2024
Decision Date	August 23, 2024
Days to Decision	22 days
Submission Type	Special
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.