Cleared Traditional

TMINI Miniature Robotic System

K252544 · THINK Surgical, Inc. · Orthopedic

Oct 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K252544 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 October 10, 2025, 59 days after receiving the submission on August 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252544 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2025
Decision Date	October 10, 2025
Days to Decision	59 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.