CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
510(k) K160879
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK160879 | Date20 Dec 2016 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 26 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- PML
- FDA applicant
- Medos International Sàrl
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Bone Cement, Posterior Screw Augmentation, classified as a Class II medical device. It combines high-viscosity spinal cement with fenestrated screw systems—specifically the Viper and Expedium—to provide structural support to the spine. The cement is designed to restore spinal integrity, particularly in cases where fusion is not feasible or expected, such as in advanced thoracic or lumbar spine tumors with limited patient lifespan.
The system is intended for surgical use in orthopedic settings and is supplied as a sterile, single-use product. It includes fenestrated screws for spinal stabilization and is regulated under the FDA’s 510(k) pathway with a Substantially Equivalent determination. The device is not MRI-safe, and sizes are determined by the specific screw system components. Storage and handling follow standard sterile surgical protocols as defined by the manufacturer.
Other devices from Medos International SARL
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Confidence™ High Viscosity Spinal Cement with Viper® and Expedium® Fenestrated Screw Systems?
The Confidence™ system combines high-viscosity spinal cement with fenestrated screws to provide structural support for the spine in cases where traditional fusion is not feasible or expected. This is particularly useful for patients with advanced thoracic or lumbar spine tumors, especially those with limited life expectancy, helping to restore spinal integrity and stability.
How is the Confidence™ system supplied, and is it reusable?
The Confidence™ High Viscosity Spinal Cement and associated fenestrated screws are supplied as a sterile, single-use product. This ensures patient safety by preventing cross-contamination and maintains the integrity of the device for one surgical procedure only.
Are there specific storage requirements for the Confidence™ system, and how should it be handled?
The system follows standard sterile surgical protocols for storage and handling, as outlined by the manufacturer. This means it should be stored in a clean, dry environment, protected from contamination, and handled using aseptic techniques to preserve sterility until use.
What regulatory pathway was used for FDA clearance of this device, and what does that mean for clinicians?
The Confidence™ system was cleared through the FDA’s 510(k) pathway with a *Substantially Equivalent* determination, meaning it was found to be as safe and effective as a legally marketed device that is not subject to premarket approval. This classification confirms its suitability for orthopedic spinal stabilization procedures as described in the device’s intended use.
How do the Viper® and Expedium® fenestrated screws differ in terms of sizing or application within this system?
The Viper® and Expedium® fenestrated screws are part of the same system but may vary in design and sizing to accommodate different anatomical requirements. Sizes are determined by the specific screw system components included in the kit, which are tailored for posterior spinal stabilization. The manufacturer’s documentation should be consulted to match the appropriate screw size to the patient’s clinical needs.