Identity
- Trade Name
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR FDA PMA
- Generic Name
- Stimulator, bone growth, non-invasive FDA PMA
Identifiers
- PMA Number
- P910066 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 Orthologic 1000 Bone Growth Stimulator is a non-invasive device classified as a bone growth stimulator. It is designed to promote bone healing and growth through the application of electrical stimulation, aiding in the treatment of orthopedic conditions such as fractures or delayed unions.
This device is supplied as a reusable medical instrument and is regulated under FDA Premarket Approval (PMA) with the designation P910066. It operates in an orthopedic clinical setting and adheres to regulatory standards outlined in 21 CFR 890.5870, ensuring compliance with safety and performance requirements for bone growth stimulation.
Frequently asked questions
Is the Orthologic 1000 Bone Growth Stimulator intended for single-use or can it be reused in clinical settings?
The Orthologic 1000 Bone Growth Stimulator is explicitly described as a reusable medical instrument. Since it is classified as a Class II device under FDA regulations and requires Premarket Approval (PMA), its design and construction must support repeated use while maintaining safety and performance standards for orthopedic applications.
What types of orthopedic conditions is the Orthologic 1000 Bone Growth Stimulator primarily used to address?
The device is designed to promote bone healing and growth through electrical stimulation, specifically aiding in the treatment of fractures or delayed unions—common orthopedic conditions where bone regeneration is critical. It is not intended for soft tissue or non-bone-related applications.
How is the regulatory approval process for the Orthologic 1000 Bone Growth Stimulator structured, and what does the PMA designation entail?
The Orthologic 1000 underwent FDA Premarket Approval (PMA), a rigorous review process for higher-risk medical devices. The PMA number P910066 confirms it was evaluated for safety and effectiveness in promoting bone growth, with compliance verified under 21 CFR 890.5870. This designation ensures the device meets stringent standards before clinical use.
Are there multiple models or variations of the Orthologic 1000 Bone Growth Stimulator, and how are they differentiated?
While the trade name remains consistent as the Orthologic 1000, the OpenFDA registration numbers (e.g., 3010032952, 3027669735) suggest multiple FEI (Facility Establishment Identifier) records, which may indicate variations in manufacturing lots, configurations, or minor updates. However, no specific model distinctions (e.g., size, output settings) are detailed in the provided data.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910066 | N/A | Active |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA PMA P910066 24 fields · synced Sep 18, 2026