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U.S. Department of Health and Human Services

Product Classification

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Device hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated 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 This device is intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene containing an additive such as a-tocopherol articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The stem/shell are coated with a porous coating to achieve cementless biological fixation.
Target Area Hip
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOQG
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 888.3358
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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