Product Classification

• Device: cement, bone, pre-formed, modular, polymeric, vertebroplasty
• Regulation Description: Polymethylmethacrylate (PMMA) bone cement.
• Definition: Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
• Physical State: Interlocking pre-formed polymeric (e.g., PEEK) components sized to the desired vertebral body dimensions
• Technical Method: Implanted modularly within the vertebral body until desired height is achieved, then encapsulated in PMMA.
• Target Area: Thoracic or lumbar vertebral bodies
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: OBL
• Premarket Review: Restorative, Repair and Trauma Devices (DHT6C); Restorative, Repair and Trauma Devices (DHT6C)
• Submission Type: 510(k)
• Regulation Number: 888.3027
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-424 ASTM F983-24
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-425 ASTM F565-21
  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

• Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement

Third Party Review

Not Third Party Eligible