510(k) · Cleared
ClearedSpinalogic 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
Cleared on Sep 29, 2026 as substantially equivalent to P910066 (Djo, LLC, 1994) after a 60-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 29, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- LOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P910066 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backP910066 Orthologic (TM)1000 Bone Growth StimulatorDjo, LLC · 1994
- This deviceK262721 Spinalogic Bone Growth StimulatorDjo, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P910066 | Orthologic (TM)1000 Bone Growth Stimulator | Djo, LLC | 1994 | — |
| 0 (this device) | K262721 | Spinalogic Bone Growth Stimulator | Djo, LLC | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P910066 | Orthologic (TM)1000 Bone Growth StimulatorSummary page 5…Spinalogic Bone Growth Stimulator Predicate Manufacturer DJO, LLC Predicate Submission / Authorization P910066/S011 (reclassified into Class II via Final Order 91 FR 20352, effect… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no 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. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Spinalogic is a portable, battery powered, micro-controlled, noninvasive bone growth stimulator indicated for skeletally mature patients as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels and adjunct use following primary anterior cervical discectomy and fusion (ACDF) surgery of 2 motion segments (3 vertebrae) from C4 - C7.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262721: Spinalogic Bone Growth Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262721
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026