V-Steady, V-Fast Bone Cement

Full name

V-Steady, V-Fast

510(k) Number

K150408 ↗

FDA Product Code

LOD

FDA applicant

G21, S.R.L.

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What are the key differences between the V-Steady and V-Fast Bone Cements in terms of their application characteristics?

  The primary difference lies in their working time: the V-Fast Bone Cement has a working time of approximately 14 minutes, which is shorter than the V-Steady. This faster setting time may be advantageous in procedures where quick application and consolidation are critical, while the V-Steady may offer slightly more flexibility in handling during surgery. Both are designed to minimize leakage risks during application and provide structural support for vertebral consolidation and orthopedic applications.

• How should the V-Steady or V-Fast Bone Cement be stored, and what are the implications for its shelf life?

  The V-Steady and V-Fast Bone Cements must be stored under controlled conditions as specified by the manufacturer. Since they are supplied as sterile, single-use systems, proper storage ensures sterility and maintains the integrity of the product until use. The exact storage conditions (e.g., temperature, humidity) are not detailed here, but adherence to manufacturer guidelines is critical to preserve the product’s performance and safety. Shelf life would also depend on these controlled conditions, so always follow the manufacturer’s instructions.

• Are the V-Steady and V-Fast Bone Cements reusable, and if not, how should they be disposed of after use?

  No, the V-Steady and V-Fast Bone Cements are designed as single-use systems. After use, they should be disposed of according to standard medical waste protocols for biological materials, ensuring compliance with local regulations and hospital policies for hazardous or infectious waste disposal. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathways have the V-Steady and V-Fast Bone Cements undergone, and what does this mean for clinicians?

  The V-Steady and V-Fast Bone Cements have undergone FDA 510(k) clearance and comply with the Medical Device Directive (MDD) in Europe. This means they have been evaluated for safety and effectiveness by regulatory authorities and are considered substantially equivalent to predicate devices in the U.S. Clinicians can rely on these pathways as evidence of the products’ compliance with stringent regulatory standards, though they should always refer to the manufacturer’s instructions for proper use and handling.

• Can the V-Steady or V-Fast Bone Cement be visualized using radiographic imaging, and why is this important?

  Yes, both the V-Steady and V-Fast Bone Cements are radiopaque, meaning they can be visualized using radiographic imaging (e.g., X-rays). This feature is critical for confirming proper placement during spinal or orthopedic procedures, ensuring the cement has consolidated correctly and is positioned as intended. Radiographic visualization helps clinicians verify clinical efficacy and avoid complications related to improper placement.