FDA product code · Orthopedic
Posterior Metal/Polymer Spinal System, Fusion
22 FDA decisions since 2004. 510(k) reviews decided 2021–2025 took a median of 29 days (half between 29 and 29). 50 recalls name this code, 0 of them Class I. The most-cited predicate is K031511, named by 8 later devices.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NQP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NQP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NQP
70in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQP
6in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQP
8in 2025
MAUDE reports naming product code NQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 34 | 45 |
| 2008 | 6 | 156 | 4 | 101 |
| 2009 | 3 | 70 | 6 | 109 |
| 2010 | 2 | — | 0 | 119 |
| 2011 | 0 | — | 0 | 60 |
| 2012 | 0 | — | 6 | 66 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 79 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
Planning a device in NQP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 888.3070.