FDA product code · Orthopedic
Stimulator, Bone Growth, Non-Invasive
12 FDA decisions since 1979. 1 recall names this code; it is not Class I. The most-cited predicate is P910066, named by 1 later device.
A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LOF 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 · LOF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOF
Too few LOF 510(k)s in any year since 2007 to give a median.
Recalls per year · LOF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOF
163in 2025
MAUDE reports naming product code LOF, 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 | — | 0 | 8 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 4 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 9 | — | 0 | 8 |
| 2012 | 2 | — | 0 | 5 |
| 2013 | 3 | — | 0 | 13 |
| 2014 | 7 | — | 0 | 3 |
| 2015 | 7 | — | 0 | 31 |
| 2016 | 8 | — | 0 | 48 |
| 2017 | 5 | — | 0 | 55 |
| 2018 | 10 | — | 0 | 36 |
| 2019 | 8 | — | 0 | 54 |
| 2020 | 3 | — | 1 | 142 |
| 2021 | 2 | — | 0 | 246 |
| 2022 | 7 | — | 0 | 158 |
| 2023 | 5 | — | 0 | 148 |
| 2024 | 5 | — | 0 | 173 |
| 2025 | 2 | — | 0 | 163 |
| 2026 | 3 | — | 0 | — |
Planning a device in LOF? 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 890.5870.