CMW Orthopaedic Bone Cement

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Cmw Bone Cement

Generic Name

BONE CEMENT

PMA Number

N18466 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

PMA Supplement

S004

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• What types of orthopedic procedures is the CMW Orthopaedic Bone Cement designed to support?

  The CMW Orthopaedic Bone Cement is specifically designed to fixate orthopedic implants during procedures like joint replacements (such as arthroplasty) and fracture repair surgeries. It bonds to bone and prosthetic components, providing mechanical stability and long-term implant integration within the skeletal system.

• Is the CMW Orthopaedic Bone Cement reusable or intended for single-use only?

  The CMW Orthopaedic Bone Cement is supplied as a sterile, single-use kit. It must be handled according to manufacturer instructions to maintain sterility and performance, ensuring it is not reused.

• How is the CMW Orthopaedic Bone Cement packaged, and what precautions should be taken during handling?

  The CMW Orthopaedic Bone Cement is packaged in sterile, sealed containers to preserve its integrity. To maintain sterility and performance, it must be handled carefully following the manufacturer’s instructions, particularly in orthopedic surgical settings.

• What regulatory pathway was followed for the approval of the CMW Orthopaedic Bone Cement?

  The CMW Orthopaedic Bone Cement received FDA Premarket Approval (PMA N18466) under the regulatory pathway for Class II medical devices. This approval was granted following a thorough review process by the FDA, ensuring its safety and effectiveness for orthopedic applications.

• Are there different sizes or models of the CMW Orthopaedic Bone Cement available?

  The provided data lists multiple FEI numbers and registration numbers, indicating that the CMW Orthopaedic Bone Cement may be available in various formulations or configurations (e.g., different lot or batch identifiers). However, specific size or model distinctions (such as volume or viscosity variations) are not detailed in the data. For precise sizing or model options, refer to the manufacturer’s product catalog or technical documentation.