# K170827: INTRACEPT Intraosseous Nerve Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Relievant Medsystems
- Decided: Aug 9, 2017 after 142 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991218 (1999). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set, Relievant Medsystems (2016) Summary page 4.

## Most influential descendants
- K190504: Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (2019), 3 descendants of its own
- K213836: Intracept Intraosseous Nerve Ablation System (2022), 1 descendant of its own
- K250213: OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (2025), 0 descendants of its own
- K222281: Intracept Intraosseous Nerve Ablation System (2022), 0 descendants of its own

## 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 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

Source page: https://510kreport.com/device/K170827
Methodology: https://510kreport.com/methodology