Palacos R Bone Cement

• • Terminated Z-0546-03 FDA Unclassified (pre-2012) ·initiated 17 Jan 2003

  There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

Generic Name

BONE CEMENT

PMA Number

P810020 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

PMA Supplement

S001

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See all devices from Smith & Nephew Richards, Inc. →

• What types of clinical applications is Palacos R Bone Cement designed for, and how does its viscosity vary for different uses?

  Palacos R Bone Cement is specifically formulated to fixate orthopedic implants such as joint replacements (e.g., hip or knee prosthetics) and fracture fixation devices by filling gaps between bone and prosthetic components. It provides both mechanical stability and biological fixation to ensure long-term implant integration. The product is available in specific viscosity grades, which are tailored to different clinical applications—such as high-viscosity for joint replacements or lower-viscosity variants for fracture fixation—to optimize handling and application during surgery.

• Is Palacos R Bone Cement intended for reuse in surgical settings, and if not, what are the implications for sterile handling?

  Palacos R Bone Cement is explicitly intended for single-use only in sterile surgical environments. This design ensures patient safety by preventing cross-contamination and maintaining sterility, as mixing the powder and liquid components requires immediate preoperative preparation. Reuse is not recommended due to potential degradation of material properties and increased infection risk.

• How is Palacos R Bone Cement supplied, and what steps must be taken before use in the operating room?

  The device is supplied as a two-part system, consisting of separate powder and liquid components that must be mixed immediately before use. This requires precise preoperative preparation in a sterile field, typically by the surgical team, to achieve the correct consistency for clinical application. The mixing process is critical to the cement’s performance and must adhere to manufacturer guidelines to avoid voids or improper curing.

• What regulatory pathway does Palacos R Bone Cement follow, and how does this affect its availability or approval status?

  Palacos R Bone Cement holds FDA Premarket Approval (PMA) under classification II, with registration number 9616671 and PMA number P810020. This approval pathway ensures the device meets stringent safety and effectiveness standards for orthopedic use. While the PMA status confirms regulatory clearance, availability depends on compliance with FDA regulations (e.g., 21 CFR 888.3027) and adherence to manufacturer distribution channels. Clinicians should verify local regulatory compliance before use.