Cleared Traditional

K112507 - RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
(FDA 510(k) Clearance)

K112507 · Mako Surgical Corporation · Orthopedic

Mar 2012

Decision

184d

Days

Class 2

Risk

K112507 is an FDA 510(k) clearance for the RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on March 1, 2012, 184 days after receiving the submission on August 30, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K112507 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2011
Decision Date	March 01, 2012
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.