QNI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3044
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2025: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K251214) | Miach Orthopaedics, Inc. | 2026-01-13 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K243578) | Miach Orthopaedics, Inc. | 2025-03-06 |
| BEAR (Bridge-Enhanced ACL Repair) Implant (DEN200035) | Miach Orthopaedics, Inc. | 2020-12-16 |
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Every clearance here is in the API, with alerts when new ones post.