Product Classification

• Device: prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
• Definition: This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
• Review Panel: Orthopedic
• Product Code: NRA
• 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
• 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