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TOSCA II Anterior Cervical Plate System

by SIGNUS Medizintechnik GmbH

510(k) K080815

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK080815 Date23 Apr 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TOSCA II Anterior Cervical Plate System is a spinal fixation device classified as a spinal fixation plate, non-bioabsorbable. It is designed for anterior stabilization of the cervical spine, featuring a semi-rigid plate and screw configuration to provide structural support to the cervical vertebrae. The system includes variable-angle screws and a central graft screw, allowing for flexible placement options to accommodate different anatomical requirements. Its design prioritizes stability while maintaining a thin profile for reduced tissue disruption.

This system is supplied as a sterile, single-use device and is intended for use in surgical settings by qualified orthopedic or spinal surgeons. It is available in multiple plate and screw sizes, including lengths up to 26 mm, to accommodate varying patient anatomies. The device is regulated under FDA 510(k) clearance (K080815) and adheres to MRI safety standards for non-ferromagnetic components. Proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the TOSCA II Anterior Cervical Plate System intended for, and why is it designed this way?

    The TOSCA II Anterior Cervical Plate System is designed for anterior stabilization of the cervical spine, providing structural support to cervical vertebrae after procedures like discectomies, fusions, or trauma repairs. Its semi-rigid plate and variable-angle screws allow for flexible placement, accommodating different anatomical needs while minimizing tissue disruption. The thin-profile design reduces invasiveness, making it suitable for delicate cervical surgeries where precision and stability are critical.

  • Is the TOSCA II Anterior Cervical Plate System reusable, and if not, how should it be handled to ensure safety and sterility?

    The TOSCA II Anterior Cervical Plate System is a sterile, single-use device, meaning it should only be used once per patient. To maintain sterility and functionality, it must be stored according to the manufacturer’s guidelines—typically in its original packaging, away from moisture, extreme temperatures, or contamination. Reusing it could compromise patient safety by introducing infection risks or compromising structural integrity.

  • What plate and screw sizes are available, and how do they help accommodate different patient anatomies?

    The system includes multiple plate and screw sizes, with plates available up to 26 mm in length to match varying cervical spine anatomies. The variable-angle screws and central graft screw allow surgeons to customize fixation angles and positions, ensuring secure attachment to vertebrae of different shapes and sizes. This modularity helps achieve stable support while minimizing the risk of hardware failure or loosening.

  • Can this device be used in patients who require MRI scans after surgery, and why?

    Yes, the TOSCA II Anterior Cervical Plate System is designed with non-ferromagnetic components, making it MRI-safe for post-operative imaging. This is important because cervical spine patients often need follow-up MRIs to monitor healing, disc integrity, or potential complications like nerve compression. The non-ferromagnetic materials ensure the device won’t interfere with MRI scans or cause patient injury.

  • Who should perform surgery using the TOSCA II Anterior Cervical Plate System, and what training or expertise is required?

    This device is intended for use by qualified orthopedic or spinal surgeons with experience in anterior cervical spine procedures. While the system is designed for ease of use, its precise placement and anatomical considerations require surgical skill to avoid complications like hardware failure, nerve damage, or improper fusion. Surgeons should be familiar with cervical spine anatomy and fixation techniques to maximize outcomes.