Identity
- Trade Name
- Xstim Spine Fusion Stimulator FDA PMA
- Generic Name
- Stimulator, bone growth, non-invasive FDA PMA
Identifiers
- PMA Number
- P230025 FDA PMA
- FDA Product Code
- LOF FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 890.5870 FDA PMA
- Regulation Number
- 890.5870 FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Xstim Spine Fusion Stimulator is a non-invasive bone growth stimulator (generic name: Stimulator, bone growth, non-invasive) designed as an adjunct electrical treatment for lumbar spinal fusion surgery. It is intended for use in adult patients to promote bone growth at one or two spinal levels following surgical intervention.
This device is supplied as a single-patient-use system and is regulated under FDA Premarket Approval (PMA P230025). It operates via capacitive coupling technology, delivering low-level electrical stimulation to stimulate natural bone healing. The device is classified as a Class II medical device under FDA regulation 890.5870 and is intended for prescription use only in orthopedic settings.
Frequently asked questions
What is the primary purpose of the Xstim Spine Fusion Stimulator, and how does it work?
The Xstim Spine Fusion Stimulator is designed as an adjunct treatment to promote bone growth during lumbar spinal fusion surgery for one or two spinal levels in adult patients. It uses capacitive coupling technology to deliver low-level electrical stimulation non-invasively, stimulating natural bone healing post-surgery. It is not a standalone solution but supports the fusion process when used alongside surgical intervention.
Is the Xstim Spine Fusion Stimulator intended for single-use or reusable applications, and what does that mean for my practice?
The device is explicitly supplied as a single-patient-use system, meaning each unit is intended for one patient only and should not be reused. This design ensures sterility and safety, as reuse could compromise the integrity of the electrical components or introduce contamination risks. Clinicians should order one unit per patient to align with this usage guideline.
What regulatory pathway does the Xstim Spine Fusion Stimulator follow, and who can prescribe or use it?
The device follows the FDA Premarket Approval (PMA) pathway, with approval granted under PMA number P230025. It is classified as a Class II medical device and is intended for prescription use only in orthopedic settings. Only licensed healthcare providers may prescribe or administer it, as it is not for over-the-counter or self-use.
Are there multiple models or sizes of the Xstim Spine Fusion Stimulator, and how do I determine the correct one for a patient?
The device is listed under multiple FEI numbers (e.g., 3010032952, 3027669735), which may correspond to variations in electrode configurations or software versions, but the core functionality remains consistent—promoting bone growth at one or two lumbar levels. The specific model or variant is not detailed in the data, but the device is designed for adult patients only following lumbar spinal fusion surgery. Consult the manufacturer’s clinical guidelines or technical support to confirm compatibility with your patient’s surgical plan.
How should the Xstim Spine Fusion Stimulator be stored, and are there any special handling requirements?
While the data does not specify storage conditions explicitly, as a single-use, non-invasive medical device, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, or moisture. Follow the manufacturer’s instructions for packaging (e.g., sealed pouches) to maintain sterility until first use. Avoid exposure to direct sunlight or electromagnetic interference, which could affect its electrical components.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Xstim, Spine Fusion Stimulation Therapy, Product Info — Xstim, Spine Fusion Stimulation Therapy, Xstim Spine Fusion Stimulator - P230025 | FDA, Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230025 | N/A | Active |
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Manufacturer
- Manufacturer
- Xstim, Inc.
Sources (1)
- FDA PMA P230025 24 fields · synced Sep 18, 2026