# K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant

- Pathway: 510(k) (Traditional)
- Applicant: Miach Orthopaedics, Inc.
- Decided: Mar 6, 2025 after 107 days
- Product code: QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair)
- Device class: 2
- Regulation: 21 CFR 888.3044
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200035 (2020). 1 ancestor in all.
1 later device descends 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)
- DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant, Miach Orthopaedics, Inc. (2020) Summary page 5.

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

## Recalls of this device
- Dec 31, 2025 · Class II · Z-1220-2026: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
- Feb 2, 2023 · Class II · Z-0479-2026: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

## 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/K243578
Methodology: https://510kreport.com/methodology