G1 40 Radiopaque Bone Cement

510(k) Number

K193059 ↗

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 is the primary clinical use for the G1 40 Radiopaque Bone Cement, and why is the radiopacity feature important in this context?

  The G1 40 Radiopaque Bone Cement is specifically designed for vertebral consolidation procedures, providing structural support and stability to bone during spinal surgeries. The radiopacity feature is critical because it allows for clear radiographic visualization during and after implantation, ensuring accurate placement and monitoring of the cement within the spine. This visibility helps surgeons confirm proper positioning and assess integration with surrounding bone.

• Is the G1 40 Radiopaque Bone Cement intended for reuse, or is it meant to be used only once per patient?

  The G1 40 Radiopaque Bone Cement is explicitly supplied as a sterile, single-use product, meaning it is intended for one-time use per patient. This design ensures patient safety by preventing contamination or degradation from repeated sterilization or handling, which could compromise its structural integrity or sterility.

• How should the G1 40 Radiopaque Bone Cement be stored to maintain its sterility and performance?

  The packaging of the G1 40 Radiopaque Bone Cement is designed for aseptic conditions, meaning it must be stored according to the manufacturer’s instructions to preserve sterility and performance. Typically, this involves keeping the sealed packaging intact, away from extreme temperatures, moisture, or direct sunlight, and adhering to any expiration or handling guidelines provided by G21 S.R.L. to ensure the cement remains effective for its intended surgical use.

• What regulatory pathways has the G1 40 Radiopaque Bone Cement followed, and how does this affect its availability?

  The G1 40 Radiopaque Bone Cement has undergone FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness as a Class II medical device. This clearance allows it to be legally marketed and distributed in the U.S. and EU markets, respectively, ensuring compliance with local medical device regulations. The device’s classification as substantially equivalent (SESE) under the FDA’s traditional pathway indicates it follows established standards for orthopedic bone cements.