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510(k) Data Aggregation

    K Number
    K163589
    Device Name
    SIGN IM Nail
    Date Cleared
    2017-07-20

    (212 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGN FRACTURE CARE INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SIGN IM Nail System is indicated for tibiotalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.
    Device Description
    The SIGN IM Nail System consists of multiple components; Standard IM Nail, Interlocking Screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided non-sterile.
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    K Number
    K153759
    Device Name
    SIGN Compression Screw System
    Date Cleared
    2016-02-25

    (57 days)

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

    SIGN FRACTURE CARE INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.
    Device Description
    The SIGN Compression Screw System consists of multiple components; self-tapping compression screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided nonsterile.
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    K Number
    K152757
    Device Name
    SIGN Hip Construct (SHC)
    Date Cleared
    2015-11-13

    (50 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGN FRACTURE CARE INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.
    Device Description
    The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.
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    K Number
    K122823
    Device Name
    SIGN PEDIATRIC FIN NAIL
    Date Cleared
    2013-04-16

    (214 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGN FRACTURE CARE INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.
    Device Description
    SIGN Pediatric Fin Nail is an Intramedullary Fixation Rod designed to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments The SIGN Pediatric Fin Nails are available in a variety of lengths, shaft diameters, and fin diameters to accommodate a variety of patient anatomies. Each nail has a proximal bend and a slot at the proximal end to accept a solid 4.5mm diameter cortical bone screw for fixation and uses rigid distal fins for rotational stability. The Pediatric Fin Nail may be removed upon fracture healing. The Pediatic Fin Nail is a single use device, supplied non-sterile, and manufactured from stainless steel in accordance with ASTM F 138.
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