Osteoremedies, LLC - FDA 510(k) Cleared Devices

Osteoremedies, LLC is a Memphis, Tennessee-based medical device manufacturer specializing in orthopedic solutions for complex surgical infections and joint reconstruction. The company develops spacer systems, bone cements, and surgical adjuncts designed for infection management and revision procedures.

Osteoremedies has received 11 FDA 510(k) clearances from 11 total submissions since its first clearance in 2015. All submissions have focused on orthopedic devices. The company remains actively engaged in regulatory submissions, with its most recent clearance in 2025.

The company's product portfolio includes the REMEDY® spacer systems for hip, knee, and shoulder applications, SPECTRUM® GV bone cement, and complementary surgical solutions such as irrigation systems and antimicrobial wound gels. These devices address infection control and revision arthroplasty across multiple joint sites.

Explore the complete regulatory record, including device names, product codes, and clearance dates, in the 510(k) database.

Regulatory submissions have been managed by Mcra, LLC and MRC Global.