Product Classification

• Device: hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
• Regulation Description: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
• Definition: 1.Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.2.Rheumatoid arthritis.3.Correction of functional deformity.4.Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.5.Revision procedures where other treatment or devices have failed.Cemented and uncemented use.
• Physical State: May include: Acetabular Shell Acetabular Liner Femoral Head Femoral Stem Femoral Neck Instrumentation
• Technical Method: A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene containing an additive such as a-tocopherol, and used with or without bone cement.
• Target Area: hip
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: OQI
• 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 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 F2393-12 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• 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
• ASTM F603-12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• 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

Third Party Review

Not Third Party Eligible