FDA product code NQP: Posterior Metal/Polymer Spinal System, Fusion
NQP is the FDA product code for posterior metal/polymer spinal system, fusion. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 22 510(k) submissions under NQP, from 10 different applicants. The average 510(k) review took 130 days (median 78). FDA has posted 50 recalls for NQP devices.
Definition
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Classification
| Field | Value |
|---|---|
| Device name | Posterior Metal/Polymer Spinal System, Fusion |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NQP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 122 |
| 2021 | 1 | 29 |
Compare with all 510(k) review times · Search every NQP clearance
Top NQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer Spine, Inc. | 7 | 2014-01-16 |
| Paradigm Spine, LLC | 4 | 2010-07-02 |
| Medtronic Sofamor Danek USA, Inc. | 3 | 2021-01-15 |
| N Spine, Inc. | 2 | 2007-10-19 |
| Globus Medical, Inc. | 1 | 2009-02-20 |
5 more applicants have NQP clearances. See the full list in Caduvo.
Most recent NQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203678 | Medtronic Sofamor Danek USA, Inc. | CD HORIZON Spinal System | 2021-01-15 | 29 |
| K191066 | Medtronic Sofamor Danek USA, Inc. | CD Horizon Astute Spinal System | 2019-10-03 | 164 |
| K182928 | Medtronic Sofamor Danek USA, Inc. | CD Horizon Spinal System | 2019-01-11 | 81 |
| K133164 | Zimmer Spine, Inc. | DYNESYS TOP-LOADING SPINAL SYSTEM | 2014-01-16 | 91 |
| K101704 | Zimmer Spine, Inc. | ZIMMER DTO PIN PRESS INSTRUMENT | 2010-08-18 | 62 |
Recalls for NQP devices
50 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-09-04.
Frequently asked questions
What is FDA product code NQP?
NQP is the FDA product code for posterior metal/polymer spinal system, fusion. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is NQP?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQP?
Across 22 cleared submissions the average was 130 days from receipt to decision (median 78).
Which companies have the most NQP clearances?
Zimmer Spine, Inc. (7); Paradigm Spine, LLC (4); Medtronic Sofamor Danek USA, Inc. (3); N Spine, Inc. (2); Globus Medical, Inc. (1).
Have NQP devices been recalled?
Yes: 50 product recalls across 5 recall events; the most recent began 2012-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NQP
- Run a recall and safety report across every NQP manufacturer
- Watch product code NQP 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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