FDA product code · Orthopedic
Filler, Bone Void, Synthetic Peptide
3 FDA decisions since 2015. 2 recalls name this code, 0 of them Class I.
The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NOX 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 · NOX
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NOX
Too few NOX 510(k)s in any year since 2007 to give a median.
Recalls per year · NOX
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOX
9in 2025
MAUDE reports naming product code NOX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 5 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 5 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 4 | — | 1 | 2 |
| 2023 | 3 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 3 | — | 0 | 9 |
| 2026 | 4 | — | 0 | — |
Planning a device in NOX? 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) Report