Cleared Special

Mako Partial Knee Application

K172301 · Mako Surgical Corp. · Orthopedic

Nov 2017

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K172301 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 November 2, 2017, 94 days after receiving the submission on July 31, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K172301 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2017
Decision Date	November 02, 2017
Days to Decision	94 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.