Cleared Special

TSolution? One Total Knee Application

K201255 · THINK Surgical, Inc. · Orthopedic

Jun 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K201255 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 June 10, 2020, 30 days after receiving the submission on May 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K201255 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2020
Decision Date	June 10, 2020
Days to Decision	30 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.