Product Classification

• Device: prosthesis, hip, pelvifemoral resurfacing, metal/polymer
• Regulation Description: Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
• Definition: Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976.Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KXB
• Submission Type: PMA
• Regulation Number: 888.3410
• 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 14242-3 First edition 2009-03-15 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding envrionmental conditions for test
• ISO 14242-2 First edition 2000-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
• ISO 14242-1 Second edition 2012-01-15 Implants for surgery -- Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
• ASTM F603-12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• 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