Cleared Special

RESTORIS POROUS PARTIAL KNEE SYSTEM

K150410 · Mako Surgical Corporation · Orthopedic

Mar 2015

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K150410 is an FDA 510(k) clearance for the RESTORIS POROUS PARTIAL KNEE SYSTEM, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on March 20, 2015, 30 days after receiving the submission on February 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K150410 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2015
Decision Date	March 20, 2015
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530