Product Classification

• Device: bone cement
• Regulation Description: Polymethylmethacrylate (PMMA) bone cement.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LOD
• Submission Type: 510(k)
• Regulation Number: 888.3027
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F451-08 Standard Specification for Acrylic Bone Cement
• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Guidance Documents

• Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA
• Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible