Identity
- Trade Name
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A FDA PMA
- Generic Name
- Stimulator, bone growth, non-invasive FDA PMA
Identifiers
- PMA Number
- P900009 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
- APRL FDA PMA
The Exogen Ultrasound Bone Healing System Model 2A is a Stimulator, Bone Growth, Non-Invasive (per FDA classification LOF), designed to promote the healing of established nonunions through targeted, low-intensity pulsed ultrasound. This device delivers therapeutic ultrasound energy to accelerate bone regeneration in orthopedic applications, excluding cranial and spinal nonunions as per regulatory constraints.
This system is intended for home or clinical use and operates as a single-patient-use device, though reuse may be permitted under specific reprocessing protocols. It is not MRI-safe and requires proper storage in a clean, dry environment to maintain functionality. Authorized under FDA PMA (P900009), it complies with MDD and MDR standards, with regulatory oversight under 890.5870 for orthopedic applications. Multiple registration numbers (e.g., 3010032952) reflect its distribution across FDA-registered facilities.
Frequently asked questions
What types of bone nonunions is the Exogen Ultrasound Bone Healing System approved to treat, and where can it be used?
The Exogen System Model 2A is designed to promote healing of established nonunions in orthopedic applications, excluding cranial and spinal nonunions. It is authorized for both home and clinical use, providing flexibility for patients and healthcare providers.
Is the Exogen Ultrasound Bone Healing System intended for single-use, or can it be reused under certain conditions?
The device is classified as single-patient-use, though reuse may be permitted if specific reprocessing protocols are followed. This distinction is important for infection control and device integrity.
How should the Exogen Ultrasound Bone Healing System be stored to ensure proper functionality?
The device must be stored in a clean, dry environment to maintain its functionality. This prevents damage from moisture or contaminants, which could compromise performance.
What regulatory pathways does the Exogen Ultrasound Bone Healing System follow, and what does this mean for its use?
The device is authorized under an FDA Premarket Approval (PMA) with number P900009, indicating it has undergone rigorous review for safety and effectiveness. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) standards, ensuring global regulatory alignment.
What does the product code LOF indicate about the Exogen Ultrasound Bone Healing System’s classification?
The product code LOF stands for 'Stimulator, Bone Growth, Non-Invasive (Low Energy)' as classified by the FDA. This classification reflects its non-invasive nature and its use of low-intensity pulsed ultrasound to promote bone healing.
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: EXOGEN Knochenheilungs-Ultraschallsystem, Exogen – Wikipedia, Was ist EXOGEN - EXOGEN Knochenheilungs-Ultraschallsystem, Ultrasound Bone Healing with Exogen - Bioventus, Wiederherstellungstherapie - Bioventus
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | N/A | Active |
| EUDAMED | European Union | MDR | — | N/A | Active |
| FDA PMA | United States | FDA_PMA | P900009 | N/A | Active |
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Manufacturer
- Manufacturer
- Bioventus Llc
- FDA Applicant
- Bioventus, LLC
Sources (2)
- FDA PMA P900009 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026