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510(k) Data Aggregation

    K Number
    K251975
    Device Name
    Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
    Manufacturer
    Ignite OrthoMotion
    Date Cleared
    2025-09-02

    (68 days)

    Product Code
    NJD
    Regulation Number
    888.3535
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K243768,K210308,K190085,K202716,K242307
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty of the medial and/or lateral femorotibial compartments to treat one or more of the following conditions:

    • Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis.
    • Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty.
    • As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

    Fixation Methods

    Tibial trays and femoral components with engineered porous surfaces are intended for cemented or cementless use.

    Tibial trays and femoral components without engineered porous surfaces are intended for cemented use only.

    Device Description

    The subject ACHIEVE™ Partial Knee System – Porous Coated CoCrMo Femoral Component is a line extension to the ACHIEVE™ Partial Knee System (cleared via K242307). The line extension is primarily focused on the addition of a Porous Coated Cobalt Chromium Molybdenum (CoCrMo) Femoral Component into the system, but also includes some minor modifications to material, manufacturing location, and design of the Femoral Components and Tibial Trays, which were previously cleared in K242307. The Instructions for Use and Surgical Technique were updated to account for the material changes of the subject devices. The indications for use were also updated to clarify that the device is intended for use in the medial and/or lateral compartment of the tibiofemoral joint.

    The ACHIEVE™ PARTIAL KNEE SYSTEM – POROUS COATED COCRMO FEMORAL COMPONENT is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation. The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). The tibial trays and femoral components with HAnano Surface™ have an adjunct coating of hydroxyapatite (HA) on the engineered porous surfaces. All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).

    AI/ML Overview

    N/A

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