FDA Clears Game-Changing Implant For ACL Tears In Young Patients

The U.S. Food and Drug Administration (FDA) has granted Miach Orthopaedics new clearance allowing the use of its BEAR Implant for anterior cruciate ligament (ACL) tears in younger children and adolescents, marking a significant shift in treatment.

Previously approved in 2020 for skeletally mature patients age 14 and older with complete ACL tears, the BEAR Implant is the first major innovation in ACL treatment in over 30 years, offering a less invasive alternative to traditional ACL reconstruction (ACLR), which requires replacing the torn ligament with a graft. The implant enables the body to heal its own ACL, helping to restore natural knee function.

More than 5,000 patients have been treated with the BEAR Implant through clinical trials and commercial use. The expansion to younger patients is a game-changer, as ACL reconstruction surgery in growing children can risk damage to growth plates, potentially leading to limb length discrepancies and deformities.

“Surgery to fix an ACL tear is different in children because we are concerned about causing damage to the growth plates, which can lead to issues such as limb length discrepancies and angular deformities,” Dr. Sean Keyes, pediatric orthopedic surgeon at AdventHealth for Children, said in a statement. “The BEAR Implant allows us to restore the ACL to its original, natural state while preserving the growth plates. We believe this will improve the long-term health of the knee.”

For partial ACL tears, which are often managed with physical therapy, bracing, or surgery in severe cases, the BEAR Implant now offers a new, ACL-preserving option.

“Our goal in treating patients with partial tears is to return them to a healthy, stable knee in the least invasive way possible,” said Dr. Nirav Amin, orthopedic surgeon at Premier Orthopaedic & Trauma Specialists in Southern California. “Until now, our options were conservative care with a watch and wait approach or ACL reconstruction, which completely removes their remaining healthy ACL tissue. The clearance of the BEAR Implant for partial tears enables us to offer patients an ACL-preserving procedure to stabilize their knees.”

The BEAR Implant is a collagen-based medical device that is implanted between the torn ends of the ACL. Surgeons inject a small amount of the patient’s blood into the implant, which then stimulates healing and tissue regeneration, allowing the torn ligament to reconnect naturally. Unlike traditional ACL reconstruction, the BEAR Implant does not require the use of a donor tendon or a second surgical site to remove a patient’s own healthy tendon. 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.”

The BEAR Implant is now an option for adults, adolescents, and children with complete or partial ACL tears, as confirmed by MRI. This advancement is expected to benefit thousands of patients annually, particularly young athletes seeking a more natural, long-term solution for ACL repair.