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510(k) Data Aggregation

    K Number
    K243889
    Device Name
    Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
    Manufacturer
    Orthocell Ltd.
    Date Cleared
    2025-04-02

    (105 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orthocell Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remplir is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    Remplir™ is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Remplir™ is a single-ply sheet of porcine-derived, non-crosslinked collagen. It presents as a soft and pliable, white to off-white membrane with distinct smooth and rough surfaces. The primary aim of surgical repair is to re-establish nerve continuity so that regenerating axons are guided into the distal nerve stump with minimal loss of nerve fibres at the repair site. Remplir™ is designed to protect the injured nerve. The device can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form. It is wrapped around the site of nerve repair, intended to provide a favourable environment for nerve regeneration and prevent ingrowth of connective tissue. Remplir™ is supplied as a single device in a double PETG/Tyvek blister pack in a labelled cardboard box. Remplir™ is available in 4 size variants for the convenience of clinicians (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm, 40 mm x 50 mm.). All size variants are identical in composition and function.
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