Cleared Traditional

RESTORIS POROUS PARTIAL KNEE SYSTEM

K133811 · Mako Surgical Corp. · Orthopedic

Jul 2014

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K133811 is an FDA 510(k) clearance for the RESTORIS POROUS PARTIAL KNEE SYSTEM, a Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (Class II — Special Controls, product code NJD), submitted by Mako Surgical Corp. (New York, US). The FDA issued a Cleared decision on July 8, 2014, 204 days after receiving the submission on December 16, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3535.

Submission Details

510(k) Number	K133811 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2013
Decision Date	July 08, 2014
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3535
Definition	Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery.