Mako Total Hip Application 5.0— 510(k) K243751

Name: FDA 510(k) clearance K243751
Creator: U.S. Food and Drug Administration
Published: 2025-03-05

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K243751 for Mako Total Hip Application 5.0, Substantially Equivalent on 2025-03-05. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-12-05
Decision date: 2025-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

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K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Mako Surgical Corp.

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K260222 — Mako Total Knee Application2026-02-25
K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer2025-04-25
K242373 — Mako Shoulder Application (1.0)2024-11-07
K241011 — Mako Total Knee Application2024-06-11
K220930 — Restoris Multi-Compartmental Knee System2022-06-02

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, 2020-01-01 through 2026-04-23. 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.