Identifiers
- 510(k) Number
- K153237 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OrthAlign Plus System is a spinal orthotic device designed to provide non-invasive, non-surgical correction and support for spinal deformities, including scoliosis. It utilises customisable, three-dimensional moulding to apply targeted forces to the spine, promoting alignment and posture correction without surgical intervention.
This system is supplied as a reusable, adjustable orthotic device intended for clinical use under medical supervision. It is not sterile and requires proper cleaning and maintenance as per manufacturer guidelines. The device is authorised under FDA 510K clearance (K153237) and complies with MDD and MDR regulations. Sizing and customisation are tailored to individual patient anatomy, ensuring a precise fit for effective spinal alignment.
Frequently asked questions
What types of spinal deformities is the OrthAlign Plus System designed to address, and how does it work to correct them?
The OrthAlign Plus System is specifically designed for non-invasive, non-surgical correction and support of spinal deformities like scoliosis. It achieves this through customisable, three-dimensional moulding that applies targeted forces to the spine, helping to gradually realign the curvature and improve posture without surgery. The adjustable nature of the device allows for personalised fitting to each patient’s anatomy, ensuring optimal support and correction.
Is the OrthAlign Plus System intended for single-use or reusable applications, and what maintenance is required?
The OrthAlign Plus System is a reusable orthotic device, meaning it is designed for repeated use under clinical supervision. Since it is not sterile, proper cleaning and maintenance are required as outlined by the manufacturer to ensure hygiene and longevity. Regular upkeep is essential to maintain its effectiveness and prevent contamination.
How is sizing and customisation handled for the OrthAlign Plus System, and why is this important?
Sizing and customisation for the OrthAlign Plus System are tailored to each patient’s unique anatomy to ensure a precise fit. This personalised approach is critical because accurate alignment and support depend on the device conforming closely to the individual’s spinal structure, maximising its ability to correct and maintain spinal posture effectively.
What regulatory pathways has the OrthAlign Plus System followed, and what does this mean for its clinical use?
The OrthAlign Plus System has undergone FDA 510(k) clearance (K153237) and complies with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). This means the device has been evaluated for safety and performance against established standards, allowing it to be legally marketed and used in clinical settings under medical supervision, particularly for non-surgical spinal correction.
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 (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153237 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthalign, Inc.
Sources (2)
- FDA 510(k) K153237 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026