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510(k) Data Aggregation

    K Number
    K173960
    Device Name
    DePuy Corail AMT Hip Prosthesis
    Manufacturer
    DePuy France S.A.S.
    Date Cleared
    2018-09-21

    (267 days)

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

    DePuy France S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty. HA coated stems of the Corail Hip System are indicated for cementless use only.
    Device Description
    The DePuy Corail AMT hip stems are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty.
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    K Number
    K123991
    Device Name
    DEPUY CORAIL AMT HIP PROSTHESIS
    Manufacturer
    DEPUY FRANCE S.A.S.
    Date Cleared
    2013-09-16

    (264 days)

    Product Code
    KWY, KWL, LZO
    Regulation Number
    888.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEPUY FRANCE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Total Hip Arthroplasty and Hemi Hip Arthroplasty Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty. HA coated stems of the Corail Hip System are indicated for cementless use only.
    Device Description
    The Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.
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    K Number
    K122442
    Device Name
    DEPUY CTA REVERSE SHOULDER SYSTEM
    Manufacturer
    DEPUY FRANCE
    Date Cleared
    2012-09-06

    (27 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEPUY FRANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in • Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. • The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. • The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.
    Device Description
    The Delta CTA™ Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.
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    K Number
    K120174
    Device Name
    DEPUT DELTA XTEND REVERSE SHOULDER
    Manufacturer
    DEPUY FRANCE
    Date Cleared
    2012-06-11

    (143 days)

    Product Code
    PHX, HSD, KWS
    Regulation Number
    888.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEPUY FRANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: - . severe arthropathy and/or; - a previously failed joint replacement and/or: ● - fracture-dislocations of the proximal humerus where the articular surface is severely . comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.
    Device Description
    The DePuy Delta Xtend™ Reverse Shoulder System is a total shoulder prosthesis that consists of monobloc and modular humeral stems, humeral cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene screws.
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