SmartPlate Gradient Plus System
510(k) K053581
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053581 | Date17 Feb 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Nuvasive Smartplate Gradient Plus System
- 510(k) Number
- FDA product code
- KWQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SmartPlate Gradient Plus System is a spinal fixation device classified as an Appliance, Fixation, Spinal Intervertebral Body, designed for anterior screw fixation in the cervical spine. It consists of modular plates, screws, and screw-retaining covers engineered to provide stabilisation as an adjunct to cervical fusion procedures, ensuring secure vertebral alignment during the healing process.
This system is supplied as a sterile, single-use orthopedic implant and is intended for use in controlled surgical environments. It is regulated under FDA 510(k) clearance (K053581) with a classification under Regulation 888.3060, adhering to orthopedic fixation standards. Multiple plate and screw configurations accommodate varying anatomical requirements, and proper storage conditions must be maintained to preserve sterility and functionality.
Other devices from Nuvasive, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the SmartPlate Gradient Plus System used for in spinal surgery?
The SmartPlate Gradient Plus System is designed specifically for anterior screw fixation in the cervical spine as an adjunct to cervical fusion procedures. It provides stabilisation by securing vertebral alignment during the healing process, ensuring proper positioning of the spine while fusion occurs.
Is this device intended for reuse in multiple surgeries, or is it single-use?
The SmartPlate Gradient Plus System is sterile and single-use only, meaning it is intended for one surgical procedure and should not be reused. This ensures patient safety and maintains device integrity.
How do I properly store the SmartPlate Gradient Plus System to maintain its sterility and functionality?
The system must be stored under controlled conditions to preserve sterility and functionality. Since it is a sterile, single-use orthopedic implant, it should be kept in its original packaging until ready for use, following manufacturer guidelines to avoid contamination or damage.
What types of configurations are available for the SmartPlate Gradient Plus System to accommodate different anatomical needs?
The system offers multiple modular plate and screw configurations, allowing surgeons to select the appropriate setup based on the patient’s cervical spine anatomy. This flexibility ensures a secure and tailored fixation solution for varying clinical scenarios.
How was the regulatory pathway for this device determined, and what does that mean for its use?
The SmartPlate Gradient Plus System was cleared through the FDA 510(k) pathway (K053581) under the classification Regulation 888.3060, which applies to spinal intervertebral body fixation appliances. This means it was determined to be substantially equivalent to a legally marketed device, ensuring it meets established safety and effectiveness standards for spinal fixation in controlled surgical settings.