Miach Orthopaedics

The BEAR® Implant by Miach Orthopaedics has demonstrated clinical efficacy as the first FDA-approved device to enable healing of a torn ACL rather than requiring reconstruction. It received De Novo approval in December 2020 for skeletally mature patients aged at least 14 with complete ACL ruptures, and in March 2025 received expanded FDA clearance for use in children/adolescents of any age and for partial ACL tears. Over 5,000 patients have been treated through clinical trials and commercial use. Clinical studies show restoration of native ACL anatomy with reduced invasiveness compared to traditional graft-based reconstruction.