ManaFuse Bone Growth Stimulator
by Enovis PMA
Active
PMA P210016
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP210016 | Date17 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- ManaFuse
- Generic Name
- Stimulator, bone growth, non-invasive
- PMA Number
- FDA Product Code
- LOF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5870
- Advisory Committee
- Orthopedic
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The ManaFuse Bone Growth Stimulator is a Stimulator, Bone Growth, Non-Invasive (per FDA nomenclature), designed for non-invasive activation of bone healing. It employs Low Intensity Pulsed Ultrasound (LIPUS) technology to stimulate natural bone regeneration in established non-unions (excluding skull and vertebral sites) and accelerate healing in specific fresh fractures, including distal radius and tibial diaphysis injuries in skeletally mature adults.
This device is supplied as a portable, battery-powered system including a transducer, coupling gel, charger, and carrying case, with all components required for daily treatment. It is intended for single-use per the manufacturer’s specifications and is regulated under FDA_PMA (PMA Number: P210016) with a classification of Class II (LOF product code). Sterility and MRI safety are not specified in the provided data, and the device is not intended for reuse.
Questions
AI-generated answers, 18 Sep 2026
What specific types of fractures and non-unions does the ManaFuse Bone Growth Stimulator treat, and how does it work?
The ManaFuse is designed for non-invasive activation of bone healing using Low Intensity Pulsed Ultrasound (LIPUS) technology. It treats established non-unions (excluding skull and vertebral sites) and accelerates healing in fresh, closed distal radius fractures or fresh, closed (or Grade I open) tibial diaphysis fractures in skeletally mature adults. The device stimulates natural bone regeneration through targeted ultrasound pulses, supporting orthopedic management like closed reduction and cast immobilization.
Is the ManaFuse Bone Growth Stimulator reusable, and what components are included in the supplied system?
The ManaFuse system is intended for single-use only, as specified by the manufacturer. Each portable system includes a battery-powered transducer, coupling gel, charger, and a carrying case—all essential components for daily treatment sessions. No reuse is permitted to maintain efficacy and safety.
How many different models or configurations of the ManaFuse are available, and are they interchangeable?
The ManaFuse system is available in multiple FEI (Final Establishment Identification) numbers, indicating distinct registration variants (e.g., 3010032952, 3027669735, etc.). While these may reflect minor variations or regional compliance requirements, the core functionality and transducer design remain consistent. Interchangeability should be confirmed with Enovis, as specific models may vary in technical specifications or regulatory compliance.
What storage requirements or handling precautions should be followed for the ManaFuse system?
The provided data does not specify sterility or MRI safety for the ManaFuse, but standard precautions for battery-powered medical devices should apply. The system should be stored in its carrying case in a clean, dry environment, away from extreme temperatures or moisture. Since it’s single-use, unused units should be kept in their original packaging until deployment. Always follow manufacturer guidelines for disposal after use.
What regulatory pathway was used to approve the ManaFuse, and what classification does it hold?
The ManaFuse Bone Growth Stimulator was approved via the FDA’s Premarket Approval (PMA) pathway, designated as a Class II device under the product code LOF (Low Energy Field). This route is typically reserved for devices with higher risk or novel technologies, ensuring rigorous evaluation of safety and efficacy before market authorization.