Product Classification

• Device: prosthesis, hip, semi-constrained, ceramic-on-metal articulation
• Definition: Intended as a primary joint replacement prosthesis in total hip arthroplasty.
• Physical State: metal femoral stem, ceramic femoral head, metal acetabular liner designed to fit within a metal acetaublar shell
• Technical Method: comprised of a metal liner designed to fit within a compatible acetabular shell which articulates with a compatible ceramic femoral head attached to a femoral stem as part of a primary total hip joint replacement system
• Target Area: hip joint
• Review Panel: Orthopedic
• Product Code: OVO
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• 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

Third Party Review

Not Third Party Eligible