The FDA granted a de novo approval to Miach Orthopaedics' Bridge-enhanced ACL Repair Implant, the company announced Dec. 17.
Physicians can use the implant to treat anterior cruciate ligament tears, a first-of-its-kind technology. Before the implant, surgeons had to surgically reconstruct a patient's ACL.
Although reconstruction restores function, a patient's knee is never the same.
This implant restores natural anatomy and function of the knee and is also less invasive. The implant, notably, doesn't require surgeons to remove a tendon like reconstruction does.
Miach Orthopaedics plans to release the BEAR Implant to market in 2021.