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K Number
K953274
Device Name
GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
Manufacturer
SMITH & NEPHEW RICHARDS, INC.
Date Cleared
1996-02-05

(206 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Genesis II Revision System is used for primary and revision surgeries with the following indications

    1. Rheumatoid arthritis.
    1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
    1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
  • The posterior stabilized knee system is designed for use in patients in primary and 4. revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Genesis II Total Knee System is indicated for use only with cement and is a single use device.

Device Description

The Genesis II Porous Tibial Trays and Revision Knee consists of the following components: Conversion Module with Taper, Distal Femoral Wedge, Stacked Distal Femoral Wedge, Long Stem Extensions, Femoral Flex-Lok Pegs, Porous Titanium Tibial Tray with and without holes, Porous Spiked Titanium Tibial Tray with and without holes, and the All Poly P/S Tibia! Component. The Conversion Module with Taper is manufactured from Co-Cr-Mo. Wedges and Long Stem Extensions are manufactured from Ti-6Al-4V. The tibial trays are manufactured from Ti-6Al-4V with a C.P. Titanium porous coating. The All Poly P/S Tibial Component and the Flex Lok Pegs are manufactured from UHMW PE

AI/ML Overview

This document does not describe an AI/ML device or a study involving such a device. The provided text is a 510(k) premarket notification for the "Genesis II Knee System," a medical device for total knee replacement. The review explicitly states that the device's safety and effectiveness are based on the long history of use of similar devices in the market and mechanical testing, not on clinical studies involving human performance or comparison with AI.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and cannot be extracted from the provided text.

The document primarily focuses on:

  • Device Description: Materials and components of the Genesis II Porous Tibial Trays and Revision Knee components.
  • Substantial Equivalence: Comparison to existing knee systems on the market.
  • Indications for Use: Conditions for which the device is intended.
  • Mechanical Testing: Listing of tests performed (device constraint, contact area, tibial tray fatigue, porous coating characterization) to demonstrate in-vivo loading capacity without failure.
  • FDA Clearance: The FDA's determination of substantial equivalence and specified limitations (e.g., cemented use only, minimum polyethylene thickness).

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.