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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 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
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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