Cleared Traditional

Mako Total Knee Application (3.0); Hybrid Tip Pointer

K250608 · Mako Surgical Corp. · Orthopedic

Apr 2025

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K250608 is an FDA 510(k) clearance for the Mako Total Knee Application (3.0); Hybrid Tip Pointer, 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 April 25, 2025, 56 days after receiving the submission on February 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K250608 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2025
Decision Date	April 25, 2025
Days to Decision	56 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.