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510(k) Data Aggregation

    K Number
    K160515
    Device Name
    PS2 Knee System
    Manufacturer
    CONSENSUS ORTHOPEDICS, INC.
    Date Cleared
    2016-12-19

    (299 days)

    Product Code
    JWH,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K945589,K100542,K143725,K110950,K932837,K951987,K954818,K962137,K001456,K133919
    Why did this record match?
    Device Name :

    PS2 Knee System

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

    The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

    The indications for use are:

    • A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
    • B. Failed osteotomy or unicompartmental replacements.
    • C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
    • D. The PS2 KNEE SYSTEM is intended for cemented use.
    Device Description

    The PS2 Knee System is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.

    AI/ML Overview

    The provided document describes the PS2 Knee System, a medical device, and its substantial equivalence to legally marketed predicate devices, rather than detailing the acceptance criteria and the study proving it meets those criteria in the context of an AI/ML device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document is for a traditional medical device (knee prosthesis), not an AI/ML device.

    The document discusses:

    • Indications for Use: What the device is intended for.
    • Substantial Equivalence: How the device is similar to previously cleared devices.
    • Non-Clinical Performance Data: Bench testing performed on the device's components to ensure safety and effectiveness, following various ASTM standards and FDA guidance for traditional medical devices. This includes topics like fatigue testing, joint stability, contact characteristics, locking mechanisms, and wear testing.

    This information is typical for a 510(k) submission for a non-AI/ML device where the primary pathway to market is demonstrating substantial equivalence to a predicate device based on material properties, design, and mechanical performance.

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