Cleared Traditional

CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM

K140585 · Curexo Technology Corporation · Orthopedic
Aug 2014
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K140585 is an FDA 510(k) clearance for the CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM, a Orthopedic Computer Controlled Surgical System (Class II — Special Controls, product code OJP), submitted by Curexo Technology Corporation (Melrose, US). The FDA issued a Cleared decision on August 18, 2014, 164 days after receiving the submission on March 7, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K140585 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2014
Decision Date August 18, 2014
Days to Decision 164 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).