Product Classification

• Device: prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
• Regulation Description: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MBH
• Submission Type: 510(k)
• Regulation Number: 888.3565
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F1800-07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• ISO 14243-3:2004 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
• ISO 14879-1:2000 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
• ASTM F1377-08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
• ISO 13779-1:2008(E) Implants for surgery - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
• ISO 13779-2:2008(E) Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite
• ASTM F1223-08 Standard Test Method for Determination of Total Knee Replacement Constraint
• ISO 14243-3:2004 Technical Corrigendum 1 Implants for surgery - Wear of total-knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
• ASTM F 1814-97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components
• ISO 14243-1 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
• ISO 14243-2 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
• 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 F2083-11 Standard Specification for Total Knee Prosthesis
• ASTM F1160-05 (Reapproved 2011) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar Prosthesis
• ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar 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

Guidance Document

• Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible