Monogram Tech Gets FDA Clearance for Total Knee Arthroplasty System

Dow Jones

May 15, 2025

By Kelly Cloonan

Monogram Technologies has received clearance from the Food and Drug Administration for its mBôs Total Knee Arthroplasty system.

The company said Wednesday the clearance means it can start marketing the device, and is preparing for initial placements with surgeons in select areas of the U.S.

The placements aim to gather real-world clinical evidence and deepen surgeon engagement, the company said.

Monogram also gained regulatory approval from India's Central Drugs Standard Control Organization to import the system and initiate a 102-patient clinical investigation to evaluate its safety and effectiveness.

The company expects patient enrollment to begin shortly, with the first live surgeries in the next 90 business days.

The clearance and regulatory approval provide a clear path to commercial adoption in key markets, Chief Executive Ben Sexson said.

Shares rose 8.8% to $2.72 in after-hours trading Wednesday.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

May 14, 2025 17:17 ET (21:17 GMT)

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