DeviceClearance

Mako Total Knee Application— 510(k) K260222

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K260222 for Mako Total Knee Application, Substantially Equivalent on 2026-02-25. Applicant: Mako Surgical Corp.. Device class: 2.

Summary

Mako Surgical's Mako Total Knee Application is filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the application beyond its name and that code name.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.

Mako Surgical filed from Weston, Florida. The decision came 30 calendar days after FDA received it (January 26 to February 25, 2026), and it was substantially equivalent.

Clearance details

Applicant
Mako Surgical Corp.
Product code
Product code OLO
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Weston, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.