PMA · Approved
Recalled · Class II · 2020Sonic Accelerated Fracture Healing System Model 2A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioventus, LLC · LOF Stimulator, Bone Growth, Non-Invasive
Approved on Oct 5, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 1,707-day review. It has been recalled 3 times.
- Decided
- Oct 5, 1994
- Review
- 1,707 days
- Class
- Class II
- Product code
- LOF
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P900009 has 44 supplements since 1995: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 5 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 4 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOF device
- #1 K262721 Spinalogic Bone Growth Stimulatorscore 12.1 · 1 generation · no Class I recall
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2020 | Class II | Z-0810-2021 | Nonconforming Material/Component | Product may contain white particulates that are microbial in nature. |
| Jun 5, 2009 | Not classified | Z-1695-2009 | Other | Problems with transducer may result in a reduced ultrasound output. |
| Jun 5, 2009 | Not classified | Z-1696-2009 | Other | Problems with transducer may result in a reduced ultrasound output. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOF devicesLOF Stimulator, Bone Growth, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P900009 · printed Nov 6, 2026
Cite this page
510(k) Report. “P900009: Sonic Accelerated Fracture Healing System Model 2A.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026