# K242121: mBôs (Monogram mBôs TKA System)

- Pathway: 510(k) (Traditional)
- Applicant: Monogram Orthopaedics, Inc.
- Decided: Mar 14, 2025 after 238 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K905070 (1991). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143752: Total Knee Application (TKA), Mako Surgical Corp. (2015) Summary page 5.

## Indications for use
The mBés TKA system is indicated for use in surgical knee procedures on adults in which the stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Total Knee Arthroplasty (TKA) The implant systems compatible with the system: mPress™ Total Knee System: mPress™ TL: Cementless mPress™ TC: Cemented Each Implant System includes the Cruciate Retaining (CR), Cruciate Substituting (CS), and Posterior Stabilized (PS) implant types.

Source page: https://510kreport.com/device/K242121
Methodology: https://510kreport.com/methodology