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510(k) Data Aggregation

    K Number
    K253488

    Validate with FDA (Live)

    Device Name
    iFuse INTRA Ti™ Implant System
    Manufacturer
    SI-BONE, Inc.
    Date Cleared
    2026-02-11

    (110 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K161210,K233508,K220195,K241504,K251780,K180818,K203247,K241574,K161616,K162733
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K161210, K233508, K220195, K241504, K251780

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iFuse INTRA Ti Implant System is intended for fusion of the sacroiliac joint for sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

    Device Description

    The iFuse INTRA Ti Implant System consists of a sterile, single-use implant with porous features designed to promote joint fusion. The implant is additively manufactured using Ti-6Al-4V ELI per ASTM F3001. The iFuse INTRA Ti instruments are single-use devices used for placement of the implant.

    AI/ML Overview

    N/A

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