PMA · Approved
Recalled · Class II · 2024Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahp Eos Buyer, Inc. · LOF Stimulator, Bone Growth, Non-Invasive
Approved on Feb 18, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 313-day review. It has been recalled 4 times.
- Decided
- Feb 18, 1986
- Review
- 313 days
- Class
- Class II
- Product code
- LOF
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P850022 has 31 supplements since 1986: 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 |
|---|---|
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 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 |
|---|---|---|---|---|
| Mar 22, 2024 | Class II | Z-1619-2024 | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment |
| Mar 22, 2024 | Class II | Z-1618-2024 | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment |
| Mar 22, 2024 | Class II | Z-1616-2024 | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment |
| Mar 22, 2024 | Class II | Z-1617-2024 | Device Design | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment |
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/P850022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P850022: Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026