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K Number
K081458
Device Name
PROVEN STEM EXTENDER
Manufacturer
STELKAST COMPANY
Date Cleared
2008-06-06

(14 days)

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

The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications:

  1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
  2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present; and
  3. Cemented use only.
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the StelKast Proven Stem Extender, a knee joint prosthesis component. This document grants market clearance based on substantial equivalence to a predicate device.

It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, clinical trial, or performance study with metrics like sensitivity, specificity, or AUC.

The document primarily focuses on:

  • Confirming 510(k) clearance for the device.
  • Indications for Use (for total knee replacement due to various conditions, revision of failed reconstructions, and cemented use only).
  • Regulatory classification and associated general controls.
  • Points of contact for regulatory guidance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

§ 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.