# K251214: BEAR® (Bridge-Enhanced ACL Restoration) Implant

- Pathway: 510(k) (Traditional)
- Applicant: Miach Orthopaedics, Inc.
- Decided: Jan 13, 2026 after 270 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
Longest line of descent: 2 generations back to DEN200035 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant, Miach Orthopaedics, Inc. (2025) Summary page 5.

## Indications for use
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.

Source page: https://510kreport.com/device/K251214
Methodology: https://510kreport.com/methodology