# K262721: Spinalogic Bone Growth Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Djo, LLC
- Decided: Sep 29, 2026 after 60 days
- Product code: LOF (Stimulator, Bone Growth, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 890.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P910066 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P910066: Orthologic (TM)1000 Bone Growth Stimulator, Djo, LLC (1994) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K262721
Methodology: https://510kreport.com/methodology