Miach Orthopaedic received FDA 510(k) clearance to expand indications of the BEAR (Bridge-Enhanced ACL Restoration) implant to include children and adolescents of any age, as well as to treat partial ACL tears. The implant previously received De Novo Approval in 2020 to treat skeletally mature patients at least 14 years of age with complete ACL tears.
Clinical evidence supporting the expanded indication included data from the BEAR III clinical trial and the Bridge Registry, for which participants have recently completed their two-year follow-up visits. To date, more than 5,000 patients have been treated with the BEAR Implant through clinical trial and commercial use.
BEAR is a proprietary collagen-based implant used to facilitate healing of the torn ACL. It acts as a bridge to help ends of the torn ACL heal together. As the ACL heals, the BEAR Implant is resorbed by the body.
“The way ACL tears are treated is reaching an inflection point, and the BEAR Implant is a significant driving force,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “Since the BEAR Implant was approved for commercial use four years ago, we have been proud to offer patients the opportunity to restore their native ACL anatomy without the need for more invasive reconstructive surgery. This FDA clearance is a significant step forward in our mission to change the standard of care in ACL surgery.”
Miach Orthopaedic received FDA 510(k) clearance to expand indications of the BEAR (Bridge-Enhanced ACL Restoration) implant to include children and adolescents of any age, as well as to treat partial ACL tears. The implant previously received De Novo Approval in 2020 to treat skeletally mature patients at least 14 years of age with complete ACL...
Miach Orthopaedic received FDA 510(k) clearance to expand indications of the BEAR (Bridge-Enhanced ACL Restoration) implant to include children and adolescents of any age, as well as to treat partial ACL tears. The implant previously received De Novo Approval in 2020 to treat skeletally mature patients at least 14 years of age with complete ACL tears.
Clinical evidence supporting the expanded indication included data from the BEAR III clinical trial and the Bridge Registry, for which participants have recently completed their two-year follow-up visits. To date, more than 5,000 patients have been treated with the BEAR Implant through clinical trial and commercial use.
BEAR is a proprietary collagen-based implant used to facilitate healing of the torn ACL. It acts as a bridge to help ends of the torn ACL heal together. As the ACL heals, the BEAR Implant is resorbed by the body.
“The way ACL tears are treated is reaching an inflection point, and the BEAR Implant is a significant driving force,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “Since the BEAR Implant was approved for commercial use four years ago, we have been proud to offer patients the opportunity to restore their native ACL anatomy without the need for more invasive reconstructive surgery. This FDA clearance is a significant step forward in our mission to change the standard of care in ACL surgery.”
Copy to clipboard 
