Cleared Special

Mako Partial Knee Application

K170584 · Mako Surgical Corp. · Orthopedic

May 2017

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K170584 is an FDA 510(k) clearance for the Mako Partial Knee Application, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on May 11, 2017, 72 days after receiving the submission on February 28, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K170584 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2017
Decision Date	May 11, 2017
Days to Decision	72 days
Submission Type	Special
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.