Product Classification

• Device: prosthesis, knee, hinged (metal-metal)
• Regulation Description: Knee joint femorotibial metallic constrained cemented prosthesis.
• Definition: Pmas to be filed by 12/26/96 (61 fr 50710 (9/27/96)).
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: HRZ
• Submission Type: PMA
• Regulation Number: 888.3480
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F 1814-97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 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
• ISO 7207-2 Second edition 2011-07-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
• ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions

Third Party Review

Not Third Party Eligible