Identifiers
- 510(k) Number
- K201136 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cure Lumbar Plate System is a spinal intervertebral body fixation orthosis, designed for surgical stabilization of the thoracolumbar (T1–L5) and lumbosacral (L1–S1) spine. It provides rigid fixation to address instability caused by fractures, dislocations, or degenerative conditions, restoring structural integrity to the affected vertebral segments. The system is intended for use via lateral, anterolateral, or anterior surgical approaches, depending on the anatomical location and vascular landmarks. Its modular design allows for customization to match specific patient anatomy and clinical needs.
This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance under product code KWQ and regulatory classification as a Class II spinal fixation orthosis. It is intended for use in an operating room setting by trained surgeons, adhering to aseptic techniques. The system’s components are compatible with MRI safety standards for non-ferromagnetic materials, though pre-implantation imaging should confirm compatibility with the specific MRI system in use. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and its use is governed by the applicable FDA-cleared indications and surgical protocols.
Frequently asked questions
What types of spinal conditions is the Cure Lumbar Plate System designed to address, and how does it differ from other fixation solutions?
The Cure Lumbar Plate System is specifically designed to stabilize the thoracolumbar (T1–L5) and lumbosacral (L1–S1) spine in cases of instability caused by fractures, dislocations, or degenerative conditions. Unlike some other fixation systems, it is modular, allowing customization to fit individual patient anatomy and surgical approaches, including lateral, anterolateral, or anterior methods. Its rigid fixation restores structural integrity to affected vertebral segments, making it suitable for complex cases where precise alignment and stability are critical.
Is the Cure Lumbar Plate System compatible with MRI scans, and what precautions should be taken before imaging?
Yes, the Cure Lumbar Plate System is designed with non-ferromagnetic materials, making it compatible with MRI safety standards. However, it is essential to confirm compatibility with the specific MRI system in use *prior* to implantation. Pre-implantation imaging should be performed to ensure the device will not interfere with the scan, as MRI protocols can vary between systems.
How is the Cure Lumbar Plate System supplied, and what are the key considerations for storage and handling?
The Cure Lumbar Plate System is supplied sterile and intended for single-use only, as indicated by its FDA clearance. Storage must adhere to the manufacturer’s guidelines to maintain sterile packaging integrity, ensuring the device remains uncontaminated until use. It is intended for use in an operating room setting by trained surgeons, requiring adherence to aseptic techniques throughout the procedure.
What surgical approaches can be used with the Cure Lumbar Plate System, and why might one approach be preferred over another?
The Cure Lumbar Plate System is compatible with lateral, anterolateral, or anterior surgical approaches, depending on the anatomical location and vascular landmarks. The choice of approach depends on factors like patient anatomy, surgical access requirements, and the specific clinical goals—such as minimizing soft tissue disruption or optimizing visualization of the target vertebrae. The modular design of the system allows for flexibility to adapt to the chosen approach.
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: Cure™ Lumbar Plate System (K201136) — FDA 510(k) | Innolitics, Cure™ Lumbar Plate System (K180090) — FDA 510(k) | Innolitics, Cure™ Lumbar Plate System (K180090) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201136 | Class II | Active |
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Manufacturer
- Manufacturer
- Meditech Spine, Llc
Sources (1)
- FDA 510(k) K201136 24 fields · synced Sep 20, 2026