Product Classification

• Device: bone cement, posterior screw augmentation
• Regulation Description: Polymethylmethacrylate (PMMA) bone cement.
• Definition: The device is intended to augment the fixation of screws in a posterior spinal system construct.
• Physical State: Viscous, polymethylmethacrylate material that set hardens over time.
• Technical Method: The device is placed within the prepared bone canal for placement of the posterior screw, and can be delivered through the screw cannulation and fenestrations.
• Target Area: Prepared bone canal in the posterior spine for placement of a screw.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: PML
• 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

Guidance Document

• Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible