Cleared Traditional

TSolution One w/ACG surgical System

K150741 · THINK Surgical, Inc. · Orthopedic

Oct 2015

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K150741 is an FDA 510(k) clearance for the TSolution One w/ACG surgical System, a Orthopedic Computer Controlled Surgical System (Class II — Special Controls, product code OJP), submitted by THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on October 22, 2015, 213 days after receiving the submission on March 23, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K150741 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2015
Decision Date	October 22, 2015
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OJP — Orthopedic Computer Controlled Surgical System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Pre-operative Planning And Intra-operative Execution Of Surgical Movements With Robotically Controlled End Effectors Under User Supervision. Alternative To Manual Planning And Broaching/reaming Techniques For Femoral Canal Preparation In Primary Total Hip Arthroplasty (tha).