Product Classification

• Device: vertebroplasty compound, calcium based
• Regulation Description: Polymethylmethacrylate (PMMA) bone cement.
• Definition: This device is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.The device resorbs (time frame may be indicated) and is replaced with bone during the healing process.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: NUD
• 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 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

Third Party Review

Not Third Party Eligible