FDA product code QNI: Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
QNI is the FDA product code for resorbable implant for anterior cruciate ligament (acl) repair. It is a Class II device, regulated under 21 CFR 888.3044 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QNI, 2 in the last five years. The average 510(k) review took 188 days (median 188); 188 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for QNI devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair |
| Device class | Class II |
| Regulation | 21 CFR 888.3044 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QNI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 107 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every QNI clearance
Top QNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miach Orthopaedics, Inc. | 2 | 2026-01-13 |
Most recent QNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251214 | Miach Orthopaedics, Inc. | BEAR® (Bridge-Enhanced ACL Restoration) Implant | 2026-01-13 | 270 |
| K243578 | Miach Orthopaedics, Inc. | BEAR® (Bridge-Enhanced ACL Restoration) Implant | 2025-03-06 | 107 |
Recalls for QNI devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-12-31.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code QNI?
QNI is the FDA product code for resorbable implant for anterior cruciate ligament (acl) repair. It is a Class II device, regulated under 21 CFR 888.3044 and reviewed by the Orthopedic panel.
What device class is QNI?
Class II, regulation 21 CFR 888.3044. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNI?
Across 2 cleared submissions the average was 188 days from receipt to decision (median 188).
Which companies have the most QNI clearances?
Miach Orthopaedics, Inc. (2).
Have QNI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-12-31.
Next steps
- Run an FDA pathway report with predicate devices for product code QNI
- Run a recall and safety report across every QNI manufacturer
- Watch product code QNI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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