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U.S. Department of Health and Human Services

Product Classification

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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 CodeOQI
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
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
Third Party Review Not Third Party Eligible
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