BEAR® (Bridge-Enhanced ACL Restoration) Implant

The BEAR® Implant is a bovine collagen and extracellular matrix-based implant for treating anterior cruciate ligament (ACL) injuries in adults, adolescents, and children. It stabilizes blood in the gap between torn ACL ends, resorbs within 8 weeks, and is replaced with fibrovascular repair tissue. The device is used with up to 10 ml of autologous blood drawn during surgery.

The device is identical to its predicate in all technological characteristics: same manufacturer (Miach Orthopaedics), same materials (bovine-derived Type 1 collagen and extracellular matrix), same dimensions (22 mm diameter, 44 mm length), same operating principle, same regulatory classification (Class II), and same intended use and indications. The only change is the addition of a labeling claim regarding reduced osteoarthritis risk at 6 years post-surgery.

ISO 10993-1 biocompatibility testing was completed for the predicate device. No new testing was required for this submission because there were no changes to device design or specifications.

The BEAR Implant is substantially equivalent to its predicate device (K243578) because it is physically and functionally identical with no design or material changes. The addition of a reduced osteoarthritis claim to labeling did not require new testing, as existing published animal data and clinical data from BEAR I and BEAR II studies support this claim. The device meets all special controls for resorbable ACL repair implants and poses no new safety or effectiveness concerns.