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510(k) K242121

mBôs (Monogram mBôs TKA System) by Monogram Orthopaedics, Inc. — Product Code OLO

K242121 is an FDA 510(k) premarket notification submitted by Monogram Orthopaedics, Inc. for the device "mBôs (Monogram mBôs TKA System)". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
July 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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FDA data resources