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K Number
K053587
Device Name
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
Manufacturer
ORTHO DEVELOPMENT CORP.
Date Cleared
2006-03-17

(84 days)

Product Code
LZO
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
K111936
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:

    1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
    1. Previously failed surgery.
  • Proximal femoral neck fractures or dislocation. 3.
    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.
    1. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Ortho Development Ceramic Femoral Heads with Press-fit Stems." It is not a study report that describes acceptance criteria and device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness. The document only confirms that the device has been found substantially equivalent to legally marketed predicate devices and lists its intended indications for use.

To answer your questions, I would need a different type of document, such as a clinical study report, a scientific paper describing the device's performance, or a detailed regulatory submission document that outlines testing and validation.

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.