Product Classification

• Device: prosthesis, knee, femorotibial, non-constrained, metal/composite cemented
• Regulation Description: Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KTX
• Submission Type: 510(k)
• Regulation Number: 888.3490
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• 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
• 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
• 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

Third Party Review

Not Third Party Eligible