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510(k) Data Aggregation

    K Number
    K253144
    Device Name
    Freedom® Total Knee System – Titan PCK Components
    Manufacturer
    Maxx Orthopedics Inc.
    Date Cleared
    2025-10-22

    (27 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K200912,K240863,K131481,K111785
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to:

    • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
    • Correction of functional deformities.
    • Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
    • Moderate valgus, varus, or flexion trauma.
    • Knee fractures untreatable by other methods.
    • Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)

    The Freedom® Total Knee System – Titan PCK Components are intended for cemented and single use only.

    Device Description

    The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785, K200912, and K240863 respectively.

    This submission seeks the clearance of Titanium Niobium Nitride (TiNbN) coated version of previously cleared Femoral Augment (non-coated version cleared in K131481), Tibial Augments, Stem Extension & Offset Junction (non-coated versions cleared in K111785). The coated versions are now branded as Freedom® Total Knee System – Titan PCK Components.

    Below is the description of the coated components.

    Freedom® Titan Femoral Augments

    The Freedom® Titan Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the internal distal and posterior surfaces of the previously cleared PCK Stemmed Femoral Component (K131481) and Titan PCK Stemmed Femoral Component (K240863) when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.

    Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Femoral Component and other augments.

    The Freedom® Titan Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.

    Freedom® Titan Tibial Augments

    The Freedom® Titan Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the distal surface of the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side.

    Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.

    Freedom® Titan Offset Junction

    The Freedom® Titan Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). Offset Junctions are intended to be used with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) to provide an additional 4mm or 6mm offset between the tibial keel and stem. The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.

    Freedom® Titan Stem Extension

    The Freedom® Titan Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). The Titan Stem Extensions are intended for use with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863). The Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.

    AI/ML Overview

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