Product Classification

• Device: prosthesis, ankle, cemented, non-constrained
• Regulation Description: Ankle joint metal/polymer non-constrained cemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KXC
• Submission Type: PMA
• Regulation Number: 888.3120
• Device Class: 3
• 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
• ASTM F732-00 (Reapproved 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

Third Party Review

Not Third Party Eligible