Product Classification

• Device: prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
• Regulation Description: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MEH
• Submission Type: 510(k)
• Regulation Number: 888.3353
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F1440-92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
• 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
• ASTM F1875-98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
• ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• 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
• AAMI/ANSI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
• ASTM F2068-09 Standard Specification for Femoral Prostheses - Metallic Implants
• ASTM F2068-09 Standard Specification for Femoral Prostheses - Metallic Implants
• ISO 7206-6 First edition 1992-03-15 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
• ASTM F2033-12 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Mateirals
• ASTM F 2345-03 (Reapproved 2008) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip-joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 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