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510(k) Data Aggregation

    K Number
    K241932
    Device Name
    OSSIOfiber® Compression Staple
    Manufacturer
    OSSIO Ltd.
    Date Cleared
    2024-08-28

    (58 days)

    Product Code
    MNU
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    MNU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.
    Device Description
    The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D, Llactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only. They are available in several sizes: 9-25 mm bridge lengths, and 10-22 mm leg lengths. The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
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    K Number
    K233302
    Device Name
    OSSIOfiber® Compression Staple
    Manufacturer
    Ossio Ltd.
    Date Cleared
    2023-11-16

    (48 days)

    Product Code
    MNU
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    MNU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.
    Device Description
    The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy. fusion, or fracture. Substantial decradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only, and nonpyrogenic. The additional devices included in this submission are: 9 x 10mm, and 11 x 10 mm. The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
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    K Number
    K212594
    Device Name
    OSSIOfiber® Staple
    Manufacturer
    OSSIO Ltd.
    Date Cleared
    2022-01-21

    (158 days)

    Product Code
    MNU
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    MNU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber® Staples must be adapted to the indication.
    Device Description
    The OSSIOfiber® Staple is a fixation implant made of degradable poly (L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths. The OSSIOfiber® Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
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    K Number
    K011172
    Device Name
    ARTHREX BIO-TRANSFIX
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2001-06-19

    (63 days)

    Product Code
    MNU, HTY, JDR
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    MNU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopaedic procedures.
    Device Description
    The Arthrex Bio-Transfix, composed of poly(L-lactide), is a cannulated pin having a diameter of approximately 5 mm and an overall length of 50 mm. One end is tapered 11.684 mm to a minor diameter of 1.422 mm. The other end has three barbs for cortical fixation and a spherical fitting for its driver.
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