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U.S. Department of Health and Human Services

Product Classification

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Device acetabular cup orientation system
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Definition The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
Physical State A patient-matched acetabular guide, made of polymeric material and with a patient-matched surface that is congruent to the mating acetabular surface. May be manufactured through an additive manufacturing process.
Technical Method The device consists of a software component that generates a pre-operative plan based on the medical imaging data and a hardware component, the patient-matched guide that is positioned onto/within the acetabulum by mating the patient-specific contact surface to its corresponding anatomical surface. The guide is used to place an alignment pin at/near the acetabular rim in a pre-operatively desired orientation. The alignment pin is used as a visual reference to assist in the intra-operative orientation of the acetabular component during THA, so the surgeon may visually ensure that the orientation of the alignment pin matches the normal direction of the acetabular component.
Target Area Acetabulum
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePLW
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible