Cleared Special

Mako Total Knee Application

K260222 · Mako Surgical Corp. · Orthopedic

Feb 2026

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K260222 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 February 25, 2026, 30 days after receiving the submission on January 26, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K260222 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2026
Decision Date	February 25, 2026
Days to Decision	30 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.