# DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant

- Pathway: De Novo (Direct)
- Applicant: Miach Orthopaedics, Inc.
- Decided: Dec 16, 2020 after 195 days
- Product code: QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair)
- Device class: 2
- Regulation: 21 CFR 888.3044
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant (2025), 1 descendant of its own
- K251214: BEAR® (Bridge-Enhanced ACL Restoration) Implant (2026), 0 descendants of its own

## Indications for use
The BEAR® (Bridge Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.

Source page: https://510kreport.com/device/DEN200035
Methodology: https://510kreport.com/methodology