Deployment

The Monogram mBos TKA System is Monogram's robotic total-knee-arthroplasty platform, recorded in the surgical form factor as the autonomy-boundary case of the orthopedic sub-cohort: unlike the AI-augmented surgeon-controlled systems Stryker Mako, Smith+Nephew CORI, and Zimmer Biomet ROSA, where the surgeon makes the cuts, the cleared mBos is semi-autonomous, with the robotic arm executing the bone cuts itself under AI control within a surgeon-approved, patient-specific CT-based plan and active surgeon supervision. It pairs CT-based pre-operative planning and predictive navigation with a robotic arm, built on a KUKA arm, that executes optimized cutting and insertion paths for Monogram's mPress press-fit implants. The system received FDA 510(k) clearance on March 17, 2025, although the precise cleared indication wording and the K-number could not be independently verified and the semi-autonomous characterization is sourced to Zimmer Biomet and trade coverage rather than the FDA letter, which Monogram's own clearance release described more softly as robotic-assisted TKA. A separate fully-autonomous, hands-free, saw-based version is not FDA cleared and remains in development, targeted around late 2027 or 2028; its first live-patient procedure was performed on July 26, 2025 at Krishna Shalby Hospital in Ahmedabad, India under an India CDSCO approval for a 102-procedure investigation, not under US FDA, as a single index case without verified peer-reviewed outcomes. Made by Monogram Technologies, founded in 2015 as Monogram Orthopaedics by orthopedic surgeon Dr. Doug Unis, who is chief medical officer and founder rather than chief executive, with Benjamin Sexson as the pre-acquisition CEO, and renamed Monogram Technologies in May 2024 trading on NASDAQ as MGRM, the company was acquired by Zimmer Biomet with the deal closing October 7, 2025 at about 168 million dollars enterprise value plus contingent value rights, making Monogram a Zimmer Biomet subsidiary with commercialization alongside Zimmer Biomet implants targeted for early 2027. The registry records the system at research maturity because it is cleared but pre-commercial with no units sold, and its headline fully-autonomous capability remains in development.

mBos TKA System by Monogram Technologies · Catalog entry · 2 sources · not yet field-verified