Product Classification

• Device: prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Definition: This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis.It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
• Review Panel: Orthopedic
• Product Code: NJL
• Submission Type: PMA
• 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 F2083-11 Standard Specification for Total Knee Prosthesis
• 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
• 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