Cleared Special

TSolution One Total Knee Application

K203040 · THINK Surgical, Inc. · Orthopedic

Nov 2020

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K203040 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 November 13, 2020, 38 days after receiving the submission on October 6, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K203040 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 06, 2020
Decision Date	November 13, 2020
Days to Decision	38 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.