Cleared Traditional

RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM

K090763 · Mako Surgical Corporation · Orthopedic

Jun 2009

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K090763 is an FDA 510(k) clearance for the RESTORIS MULTICOMPARTMENTAL KNEE (MCK) 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 June 17, 2009, 86 days after receiving the submission on March 23, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K090763 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2009
Decision Date	June 17, 2009
Days to Decision	86 days
Submission Type	Traditional
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.