mBôs (Monogram mBôs TKA System)— 510(k) K242121

Name: FDA 510(k) clearance K242121
Creator: U.S. Food and Drug Administration
Published: 2025-03-14

Substantially Equivalent

Monogram Orthopaedics, Inc.

FDA 510(k) clearance K242121 for mBôs (Monogram mBôs TKA System), Substantially Equivalent on 2025-03-14. Applicant: Monogram Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Monogram Orthopaedics, Inc.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-07-19
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View 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, 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.