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510(k) Data Aggregation

    K Number
    K192156
    Device Name
    Cartiva SCI instrumentation set
    Manufacturer
    Cartiva, Inc.
    Date Cleared
    2019-09-04

    (26 days)

    Product Code
    QBO
    Regulation Number
    888.4505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cartiva, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
    Device Description
    Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
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    K Number
    K181348
    Device Name
    Cartiva SCI Disposable Instrumentation Set
    Manufacturer
    Cartiva, Inc.
    Date Cleared
    2018-06-20

    (30 days)

    Product Code
    QBO
    Regulation Number
    888.4505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cartiva, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
    Device Description
    Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
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    K Number
    K142490
    Device Name
    ProxiFuse Hammer Toe Device
    Manufacturer
    Cartiva, Inc.
    Date Cleared
    2014-12-15

    (102 days)

    Product Code
    HWC, HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cartiva, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
    Device Description
    The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2) deployment instrumentation, and 3) bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves multiple functions: 1) shifting of the PEEK Body and 2) applying tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint (PIPJ).
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