Cleared Traditional

TSolution One Total Knee Application

K191369 · THINK Surgical, Inc. · Orthopedic

Oct 2019

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K191369 is an FDA 510(k) clearance for the TSolution One Total Knee Application, 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 8, 2019, 139 days after receiving the submission on May 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K191369 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2019
Decision Date	October 08, 2019
Days to Decision	139 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.