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510(k) Data Aggregation

    K Number
    K163585
    Device Name
    Responsive Orthopedics Total Hip Arthroplasty System
    Manufacturer
    Responsive Orthopedics, LLC
    Date Cleared
    2017-06-02

    (164 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    Responsive Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases: - · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - · Rheumatoid arthritis; - · Correction of functional deformity; - · Revision procedures where other treatments or devices have failed; and · Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.
    Device Description
    The Responsive Orthopedics Total Hip Arthroplasty (RO THA) System is a total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint. The system includes both femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
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