Cleared Traditional

Mako Total Hip Application 5.0

K243751 · Mako Surgical Corp. · Orthopedic

Mar 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K243751 is an FDA 510(k) clearance for the Mako Total Hip Application 5.0, 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 March 5, 2025, 90 days after receiving the submission on December 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K243751 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2024
Decision Date	March 05, 2025
Days to Decision	90 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.