PMA · Approved
ApprovedOrthologic (TM)1000 Bone Growth Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · LOF Stimulator, Bone Growth, Non-Invasive
Approved on Mar 4, 1994 through premarket approval, which rests on the device’s own clinical evidence after an 837-day review. 1 later device descends from it.
- Decided
- Mar 4, 1994
- Review
- 837 days
- Class
- Class II
- Product code
- LOF
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP910066 Orthologic (TM)1000 Bone Growth StimulatorDjo, LLC · 1994
- Descendant · cites it directly · 0 of its ownK262721 Spinalogic Bone Growth StimulatorDjo, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K262721Spinalogic Bone Growth StimulatorDjo, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P910066 | Orthologic (TM)1000 Bone Growth Stimulator | Djo, LLC | 1994 | — |
| +1 | K262721 | Spinalogic Bone Growth Stimulator | Djo, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262721 | Spinalogic Bone Growth Stimulator | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K262721 (Djo, LLC, 2026) has gone furthest, with 0 descendants of its own.
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/P910066 · printed Nov 5, 2026
Cite this page
510(k) Report. “P910066: Orthologic (TM)1000 Bone Growth Stimulator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P910066
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026