# DEN250067: ReneuRx™ (Neural Ice)

- Pathway: De Novo (Direct)
- Applicant: Brixton Biosciences
- Decided: Aug 21, 2026 after 249 days
- Product code: SJA (Injectable For Thermal Treatment Of Musculoskeletal Pain)
- Device class: 2
- Regulation: 21 CFR 888.3048
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
ReneuRx™ (Neural Ice) is intended for pain management by inhibiting nerve signaling through the introduction of a multiphase suspension into the extraneural space of the target sensory nerve. The device is indicated for the management of knee pain in adults with symptomatic osteoarthritis (OA).

Source page: https://510kreport.com/device/DEN250067
Methodology: https://510kreport.com/methodology