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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Definition Intended as a primary joint replacement prosthesis in total hip arthroplasty.
Physical State metal femoral stem, ceramic femoral head, metal acetabular liner designed to fit within a metal acetaublar shell
Technical Method comprised of a metal liner designed to fit within a compatible acetabular shell which articulates with a compatible ceramic femoral head attached to a femoral stem as part of a primary total hip joint replacement system
Target Area hip joint
Review Panel Orthopedic
Product CodeOVO
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible