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510(k) Data Aggregation

    K Number
    K172235
    Device Name
    CoreHip® System
    Manufacturer
    Aesculap Implants Systems, LLC
    Date Cleared
    2018-03-28

    (246 days)

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

    Aesculap Implants Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoreHip® System is intended to replace a hip joint. The device is intended for: · Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur - · Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis - · Patients suffering from disability due to previous fusion - · Patients with acute femoral neck fractures The CoreHip® System is available with two (2) types of femoral stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.
    Device Description
    The CoreHip System includes cemented and uncemented (pressfit) stems. The CoreHip uncemented (pressfit) Stem is offered as CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended which are manufactured from Ti with a Ti plasma spray coating (Plasmapore®) proximally and rough-blasted distally. The Cemented Stem is offered as CoreHip Cemented Primary stem which is manufactured from CoCrMo. The CoreHip System includes stem variants of varus, neutral, valgus and dysplasia is offered in CoreHip uncemented (pressfit) Primary only), which have different medial curves in order to address different patient morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.
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    K Number
    K143443
    Device Name
    VEGA Knee System, Columbus Total Knee System
    Manufacturer
    Aesculap Implants Systems, LLC
    Date Cleared
    2015-03-25

    (113 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesculap Implants Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Posterior Stabilized (PS) components are also for aon-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The VEGA Knee is designed for use with bone cement. The Columbus Total Knee System is indicated for use in reconstruction of the diseased by osteoarthritis, theumatord arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Posterior Stabilized (PS) components are also for and on non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The Columbus Knee is designed for use with bone cement.
    Device Description
    All Poly Tibia posterior stabilizing and cruciate retaining implants are a line extension to the VEGA Knee System® and Columbus Total Knee System, respectively. The posterior stabilizing version is being introduced to the VEGA Knee System® and the cruciate retaining, deep dish version is being introduced to the Columbus Total Knee System. The subject implants are available with an optional centralizer. VEGA Knee System® is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. Columbus Total Knee System includes both cruciate retaining and posterior stabilizing variants of the femoral, tibial and meniscal components. For both knee systems, the femoral component, tibial plateau and extension stems are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo), available with an optional Zirconium nitride (ZrN) coating. The tibial gliding surface (insert), patella and All Poly Tibia are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The optional centralizer, designed to be used with the All Poly Tibia is made of polymethyl methacrylate (PMMA). The patella and All Poly Tibia incorporate X-ray markers. The materials of the X-ray markers in the patella are wrought stainless steel and the All Poly Tibia X-ray markers consist of a titanium peg and a tantalum ball. The tibial plug is made of PEEK. VEGA and Columbus Knee Systems are made up of numerous components available in various sizes. The VEGA Knee System® is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments. VEGA and Columbus components are sterile and intended for single use only.
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