Monogram Orthopaedics Provides Update on FDA Meeting for mBôs TKA System

Monogram Orthopaedics, a company focused on AI-driven robotics for orthopedic surgery, recently shared insights from its Submission Issue Request meeting with the U.S. Food and Drug Administration (FDA) concerning its 510(k) premarket filing submission for the mBôs TKA System. The meeting occurred on December 17, 2024, leading to positive developments as outlined in a press release issued by the company.

The initial filing for the mBôs TKA System was submitted on July 19, 2024, and after passing the initial FDA Administrative Review, Monogram received an Additional Information Request (AIR) on September 30, 2024. The FDA placed the application on hold pending a complete response to the AIR, giving Monogram 180 days for submission.

Following written responses and planned remediations for noted deficiencies in the AIR on November 20, the company requested a Submission Issue Request (SIR) meeting to review select responses. The crucial focus was on nonclinical testing’s efficacy in addressing FDA concerns that could potentially require clinical data. The SIR meeting transpired on December 17, 2024.

Management at Monogram believes their detailed plans to address the AIR could sufficiently address the agency’s concerns without necessitating clinical data. The company is actively conducting additional testing and aims to provide a comprehensive AIR response in the first quarter of 2025. Achieving FDA clearance for the mBôs TKA System is seen as a significant milestone in enhancing orthopedic medicine standards. Additionally, the company is advancing work on the next-generation mBôs TKA System.

CEO Ben Sexson highlighted the strategic significance of the recent meeting in progressing towards commercializing the mBôs TKA System and executing the long-term roadmap. He emphasized the confidence in their submission, following the FDA’s feedback during the SIR meeting.

Looking ahead, Monogram Orthopaedics anticipates responding to the FDA AIR with supplemental data in the first quarter of 2025. The company is also exploring regulatory clearance for clinical trials in India with partner Shalby Hospitals, while continuing to engage in domestic and international relationships.

For further information on Monogram Orthopaedics, including its robotics applications in orthopedic surgery, please visit www.monogramtechnologies.com.

This news release may contain forward-looking statements subject to a range of risks and uncertainties that could impact future performance. It’s important to note that actual results may vary from these statements due to various factors outlined in the company’s SEC filings. No obligation is placed on the company to update any forward-looking statements, and they are valid from the release date only.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Monogram Orthopaedics’s 8K filing here.

Monogram Orthopaedics Company Profile

Monogram Orthopaedics, Inc focuses on developing a product solution architecture to enable patient-optimized orthopaedic implants. The company intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation for use in reconstructive joint replacement procedures.