Product Classification

• Device: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
• Regulation Description: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
• Definition: Indicated for: 1.Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.2.Correction of varus, valgus, or posttraumatic deformity.3.Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.For cemented use.
• Physical State: May include: Femoral Component Tibial Component Metal Backed Patellar Component Tibial Insert Patella Insert All Poly Patellar Component Instrumentation
• Technical Method: This device is intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prosthesis that have a femoral component mode of alloys, such as cobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellar resurfacing component made of ultra-high molecular weight polyethylene plus an additive, such as a-tocopherol.
• Target Area: Knee
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: OIY
• Submission Type: 510(k)
• Regulation Number: 888.3560
• Device Class: 2
• 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
• ASTM F2083-11 Standard Specification for Total Knee 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

Third Party Review

Not Third Party Eligible