Product code QNI— Orthopedic
BEAR® (Bridge-Enhanced ACL Restoration) Implant
- Classification name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Device class
- Class 2
- Regulation
- 21 CFR 888.3044
- Advisory panel
- Orthopedic
- Total cleared
- 3
- First cleared
- Most recent
FDA classification definition
“A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.”
Market context for product code QNI
FDA has cleared devices under product code QNI between 2020 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2020
Top applicants under product code QNI
Recent clearances under product code QNI
Data sourced from openFDA. This site is unofficial and independent of the FDA.