Product Classification

• Device: prosthesis, ankle, uncemented, non-constrained
• Definition: An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
• Review Panel: Orthopedic
• Product Code: NTG
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 11-362 ISO 22622 First edition 2019-07
  Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
• 11-386 ASTM F2665-21
  Standard Specification for Total Ankle Replacement Prosthesis

Third Party Review

Not Third Party Eligible