# QNI: Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

- Device class: 2; regulation: 21 CFR 888.3044; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 107 days (middle half 107–107)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2020: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K243578: BEAR® (Bridge-Enhanced ACL Restoration) Implant (2025), cited by 1
- DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant (2020), cited by 1

Source page: https://510kreport.com/product-code/QNI
Data by year (CSV): https://510kreport.com/product-code/QNI.csv