Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3048](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3048) → SJA — Injectable For Thermal Treatment Of Musculoskeletal Pain

# SJA · Injectable For Thermal Treatment Of Musculoskeletal Pain

_Orthopedic · 21 CFR 888.3048 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SJA

## Overview

- **Product Code:** SJA
- **Device Name:** Injectable For Thermal Treatment Of Musculoskeletal Pain
- **Regulation:** [21 CFR 888.3048](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3048)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

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

## Classification Rationale

FDA concludes that this device should be classified into Class II. This order classifies the device into Class II with the establishment of special controls, which provide reasonable assurance of the safety and effectiveness of the device type.

## Special Controls

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use and include the following:
(i) Evaluation of clinically relevant endpoints, such as reduction in pain, in comparison to a clinically justified comparator; and
(ii) Evaluation of relevant adverse events, including pain, injury at injection site or tissues exposed to locations of thermal spread, any unanticipated adverse device effects, and subsequent surgical interventions.
(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Animal testing must include:
(i) Assessment of device performance, including nerve degeneration and subsequent healing response at the injection site; and
(ii) Adverse effects as assessed by gross necropsy and histopathology.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use and include the following:
(i) Performance testing must characterize the dimensions of the treatment area, flowability and spread, and temperature range; and
(ii) Simulated use testing, including device preparation and compatibility with accessories.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) A shelf life;
(ii) Identification of material composition;
(iii) A detailed summary of the clinical data pertinent to use of the device, including population studied, effectiveness outcomes and observed adverse events;
(iv) Information regarding any limitations of the clinical data; and
(v) Specific instructions regarding target nerve location and device placement.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250067](/device/DEN250067.md) | ReneuRx™ (Neural Ice) | Brixton Biosciences | Aug 21, 2026 | DENG |

## Top Applicants

- Brixton Biosciences — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SJA](https://fda.innolitics.com/productcode/SJA)

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