Surgical Simplex P Radeopaque Bone Cement

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

Generic Name

BONE CEMENT

PMA Number

N17004 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

APRL

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• What is the primary purpose of the Surgical Simplex Radioopaque Bone Cement in orthopedic procedures?

  The Surgical Simplex Radioopaque Bone Cement is specifically designed to provide mechanical stability and secure fixation in bone during orthopedic surgeries, such as joint replacements or fracture repairs. Its radiopacity allows for clear visualization on postoperative imaging, which aids in assessing the cement’s placement and integration with the bone.

• Is this bone cement intended for reuse, or is it meant to be used only once per patient?

  This product is explicitly labeled as a sterile, single-use item, meaning it is intended for one-time intraoperative use only. Reuse is not recommended or supported by the manufacturer to maintain sterility and safety.

• How should the Surgical Simplex Radioopaque Bone Cement be stored to ensure its integrity?

  The cement is supplied in sterile containers, so it must be stored in a way that preserves sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Since no specific storage instructions are provided beyond aseptic handling, adhering to standard sterile supply protocols (e.g., refrigeration if required by the manufacturer’s labeling) is advised.

• What regulatory pathway was followed for approval of this bone cement, and what does that mean for its use?

  The Surgical Simplex Radioopaque Bone Cement received Premarket Approval (PMA) from the FDA, which is the highest level of regulatory clearance for medical devices. This approval indicates that the device has undergone rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use in orthopedic procedures, ensuring it meets strict regulatory standards.