Latest medtech regulatory news

Departments - Regulatory

Novel total hip arthroplasty system; Special 510(k) submitted to FDA for Evo sEEG Electrode

October 14, 2022


Novel total hip arthroplasty system

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery announced the successful first surgeries of the Spartan Stem and Logical Cup System for total hip arthroplasty.

Featuring clinically attractive attributes, including industry-leading, three-offset options, and a tapered, polished distal segment, the Spartan Hip Stem reflects contemporary patient needs and the newest advancements in surgical approach. The Logical Cup, an advanced, modular acetabular system, is engineered to meet the demands of highly active patients while also enabling an efficient surgical workflow in hospitals and ambulatory surgical centers.

The pilot launch of the Spartan Stem and Logical Cup Systems commenced in limited regions during Q3 2022, and the commercial launch is planned to expand into most geographies across the U.S. in 1H 2023.

Special 510(k) submitted to FDA for Evo sEEG Electrode

NeuroOne Medical Technologies Corp., a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, submitted a special 510(k) to the U.S. Food and Drug Administration (FDA) for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 days. A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).