QNI — Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair Class II
FDA product code QNI covers "Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair", a Class II medical device regulated under 21 CFR 888.3044. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNI
- Device Class
- Class II
- Regulation Number
- 888.3044
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251214 | miach orthopaedics | BEAR® (Bridge-Enhanced ACL Restoration) Implant | January 13, 2026 |
| K243578 | miach orthopaedics | BEAR® (Bridge-Enhanced ACL Restoration) Implant | March 6, 2025 |
| DEN200035 | miach orthopaedics | BEAR (Bridge-Enhanced ACL Repair) Implant | December 16, 2020 |