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K Number
K050966
Device Name
PIVOT BIPOLAR FEMORAL HEAD
Manufacturer
ORTHO DEVELOPMENT CORP.
Date Cleared
2005-07-07

(80 days)

Product Code
KWY
Regulation Number
888.3390
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include:

    1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
    1. Proximal femoral neck fractures or dislocation.
    1. Idiopathic avascular necrosis of the femoral head.
    1. Non-union of proximal femoral neck fractures.
    1. Treatment of fractures that are unmanageable using other forms of therapy.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Pivot™ Bipolar Head." This document grants market clearance based on a finding of "substantial equivalence" to a predicate device.

It is critical to understand that this document does not contain acceptance criteria for the device's performance, nor does it describe a study proving the device meets performance criteria.

A 510(k) submission generally involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and, sometimes, performance data. However, the FDA letter itself is the result of a review, not the detailed study report.

Therefore, I cannot provide the requested information from the given text. The FDA clearance letter acknowledges the submission and clearance but does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test sets or data provenance.
  • Number/qualifications of experts for ground truth or adjudication methods.
  • Information on MRMC studies or standalone algorithm performance.
  • The type of ground truth used.
  • Sample size for the training set or how its ground truth was established.

This information would typically be found in the original 510(k) submission document or supporting technical reports, which are not provided here.

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.