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    K Number
    K242412
    Device Name
    Agility Symmetric™ Total Knee System
    Manufacturer
    Medisurge, LLC
    Date Cleared
    2024-11-06

    (84 days)

    Product Code
    MBH,JWH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K080199,K141635
    Why did this record match?
    Device Name :

    Agility Symmetric™ Total Knee System

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

    Indications:

    Indications for Total Knee Replacement:

      1. Rheumatoid arthritis,
      1. Correction of functional deformity.
      1. Osteoarthritis.

    1. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.

    2. Failed osteotomies, unicompartmental replacement, or total knee replacement.

    The femoral component and tibial tray are for cemented use (biological fixation).

    The patellar component and metaphyseal stem (K080199) are for cemented use only.

    Indications for Posterior Stabilized Knee Replacement:

    Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

    Indications for Constrained Knee Replacement:

    Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

    Device Description

    The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199).

    The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium.

    The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium.

    Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

    AI/ML Overview

    The prompt asks to describe the acceptance criteria and the study proving a device meets them, but the provided text is a 510(k) clearance letter for a total knee replacement system (Agility Symmetric Total Knee System). This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a clinical study with human readers or AI assistance.

    Instead, it's a premarket notification for a medical implant and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

    Therefore, I cannot fulfill the request as it pertains to an AI/ML medical device's acceptance criteria and study, based on the provided text. The text outlines:

    • Device Name: Agility Symmetric™ Total Knee System
    • Regulation Number/Name: 21 CFR 888.3565 / Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
    • Product Codes: MBH, JWH
    • Indications for Use: Total Knee Replacement, Posterior Stabilized Knee Replacement, Constrained Knee Replacement (details specific conditions like rheumatoid arthritis, osteoarthritis, failed osteotomies, ligament integrity, etc.).
    • Predicate Devices: K080199 (Symmetric™ Total Knee System - primary), K141635 (Arthrex iBalance® TKA System - secondary)
    • Device Description: Components (femoral, tibial tray, patellar, metaphyseal stem), materials (CoCrMo, Ti6Al4V), and coating (ASTM F67 titanium mesh).
    • Technological Comparison: Differences from predicates in coating material and bone interface features (e.g., removal of central post/gussets, addition of condylar pegs), but deemed to not raise new questions of safety and effectiveness.
    • Non-Clinical Tests Summary & Conclusions:
      • Fatigue testing per ASTM F3210 (femoral knee) and ASTM F1800 (tibial tray, tibial tray and modular stem).
      • Wear testing per ISO 14243-1.
      • Particle characterization per ASTM F1877-16.
      • Shear-off testing for tibial locking mechanism per ASTM 1814.
      • Cleaning validation per ISO 19227.
      • Biocompatibility assessment per ISO 10993-1.
      • Sterilization assessment per ISO 11135 and AAMI TIR28.
      • Uncemented design validation per ISO 21536.
      • Morse taper modular connection assessment per ISO 21536 and ASTM F1814.
      • Constraint and contact area assessment per ASTM F1223 and ISO 21536.
    • Clinical Testing: Not Applicable. This further confirms that no human-in-the-loop or standalone AI/ML performance study was conducted.

    In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and study data for an AI/ML medical device.

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