Cleared Special

RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

K133039 · Mako Surgical Corporation · Orthopedic

Dec 2013

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K133039 is an FDA 510(k) clearance for the RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM, a Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code NPJ), submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on December 10, 2013, 75 days after receiving the submission on September 26, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K133039 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2013
Decision Date	December 10, 2013
Days to Decision	75 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560
Definition	The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement.