Cleared Traditional

Mako Total Knee Application

K241011 · Mako Surgical Corp. · Orthopedic

Jun 2024

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K241011 is an FDA 510(k) clearance for the Mako Total Knee Application, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Mako Surgical Corp. (Weston, US). The FDA issued a Cleared decision on June 11, 2024, 60 days after receiving the submission on April 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K241011 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2024
Decision Date	June 11, 2024
Days to Decision	60 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.