BEAR® (Bridge-Enhanced ACL Restoration) Implant

The BEAR® Implant is a bovine collagen-based resorbable scaffold designed to treat anterior cruciate ligament (ACL) injuries by stabilizing blood in the gap between torn ligament ends, facilitating fibrovascular repair tissue formation over 8 weeks. It is indicated for adults, adolescents, and children with complete or partial ACL ruptures confirmed by MRI, provided they have an intact ACL stump attached to the tibia and, in children with open growth plates, sufficient epiphyseal bone to avoid disruption.

The device is identical to its predicate in physical form (22 mm diameter, 44 mm length cylinder), composition (bovine Type I collagen and extracellular matrix), sterilization method (electron-beam irradiation), and operating principle (blood stabilization over 8 weeks). The only changes are expanded indications: removal of the ≥14 years age restriction and skeletal maturity requirement, addition of pediatric patients down to age 7, inclusion of partial ACL tears, and addition of epiphyseal bone sufficiency requirements for children.

ISO 10993-1 biocompatibility testing was completed for the predicate device; no new testing was required for this submission. The document cites FDA guidance but does not reference specific ASTM, IEC, or other consensus standards for device performance or surgical testing.

Substantial equivalence is justified by: (1) identical device description, materials, design, and manufacturing process to the predicate; (2) clinical data from the BEAR III study (151 subjects ≥12 years, including 18 under age 14 and 27 with partial tears) and BRIDGE Registry showing non-inferior IKDC scores and similar safety profiles (AE/SAE rates) in younger and partial-tear populations compared to older and complete-tear populations; and (3) no new technological, manufacturing, or safety concerns raised by the indication changes, with only minor surgical modifications required to accommodate pediatric anatomy.