# Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
> **Product code: QNI** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3044
## Classification
- **FDA Product Code:** QNI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3044
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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 data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QNI)
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