MiRus, LLC - FDA 510(k) Cleared Devices

MiRus, LLC is a medical device company based in Marietta, Georgia. The company develops innovative orthopedic implants and surgical solutions.

MiRus has received 24 FDA 510(k) clearances from 24 total submissions since its first clearance in 2018. The company specializes exclusively in orthopedic devices, with a focus on spinal fusion systems, interbody fusion devices, and osteotomy solutions. Recent clearances include posterior cervical fusion systems, lumbar plating systems, and expandable wedge osteotomy devices. The company remains actively engaged in FDA submissions, with its latest clearance in 2026.

MiRus leverages a proprietary MoRe® alloy—a molybdenum-rhenium superalloy—to develop smaller, stronger, and more durable implants. This advanced biomaterial represents over 15 years of research and development. The company's integrated platform spans pre-operative, intra-operative, and post-operative solutions across spine and extremity procedures.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.