De Novo · Granted
GrantedReneuRx™ (Neural Ice)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brixton Biosciences · SJA Injectable For Thermal Treatment Of Musculoskeletal Pain
Granted on Aug 21, 2026 as a new device type through De Novo after a 249-day review.
- Decided
- Aug 21, 2026
- Review
- 249 days
- Class
- Class II
- Product code
- SJA
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SJA? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SJA devicesSJA Injectable For Thermal Treatment Of Musculoskeletal Pain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SJA
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SJA
Too few SJA 510(k)s in any year since 2007 to give a median.
Recalls per year · SJA
No recall names SJA since 2007.
Adverse event reports per year · SJA
No MAUDE report names SJA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250067 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250067: ReneuRx™ (Neural Ice).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250067
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026