# K222281: Intracept Intraosseous Nerve Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Relievant Medsystems, Inc.
- Decided: Oct 26, 2022 after 89 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K991218 (1999). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213836: Intracept Intraosseous Nerve Ablation System, Relievant Medsystems, Inc. (2022) Summary page 4.

## Recalls of this device
- Apr 22, 2026 · Class II · Z-2694-2026: Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

## Indications for use
The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

Source page: https://510kreport.com/device/K222281
Methodology: https://510kreport.com/methodology