Product Classification

• Device: prosthesis, total talus replacement, metal
• Definition: Replaces the native talus
• Physical State: Solid metallic device that is free-floating (not fixed to any bone or soft tissue)
• Technical Method: Placed between the distal tibia and calcaneus
• Target Area: Talus
• Review Panel: Orthopedic
• Product Code: QNN
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: HDE - Humanitarian Device Exemption
• Device Class: HDE
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible