K Number
K955877
Device Name
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
Manufacturer
Date Cleared
1996-10-08

(287 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Zimmer Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
Device Description
The Zimmer Zirconia Ceramic Femoral Head is made from yttria stabilized zirconia oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy, and aluminum oxide ceramic femoral heads. The Zimmer Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zimmer Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component. The prosthesis is supplied in 22, 26, and 28 mm diameters and a variety of neck lengths.
More Information

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Not Found

No
The device description and intended use are for a physical implant (femoral head) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".

Yes
The device is a component of a total hip arthroplasty, intended to alleviate severe hip pain and disability and treat various hip conditions, which directly addresses a medical condition.

No

The device is a Zimmer Zirconia Ceramic Femoral Head, an implantable component for total hip arthroplasty, not a tool for diagnosing medical conditions.

No

The device description clearly states it is a physical implant made of ceramic and metal alloys, intended for surgical implantation in the human hip. It is a hardware device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The Zimmer Zirconia Ceramic Femoral Head is an implantable medical device designed to be surgically placed within the human hip joint. It is a physical component of a total hip replacement.
  • Intended Use: The intended use clearly states it is for implantation into the human hip to treat various conditions affecting the hip joint. It does not involve the analysis of specimens taken from the body.

Therefore, based on the provided information, the Zimmer Zirconia Ceramic Femoral Head is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Zimmer Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Product codes

Not Found

Device Description

The Zimmer Zirconia Ceramic Femoral Head is made from yttria stabilized zirconia oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy, and aluminum oxide ceramic femoral heads. The Zimmer Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zimmer Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.

The prosthesis is supplied in 22, 26, and 28 mm diameters and a variety of neck lengths.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Ceramic materials have been successfully used in orthopaedic applications for approximately 20 years. These materials exhibit excellent resistance to corrosion and wear and are highly biocompatible. The yttria stabilized zirconium oxide from which the Zimmer Zirconia Ceramic Head is made has limited clinical history. Although mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates, the total amount of particulate produced remains undetermined. Because of limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Zimmer® Zirconia Ceramic Femoral Heads, 22 through 28 mm

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

OCT -8 1996

Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a smaller, sans-serif font.

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

Summary of Safety and Effectiveness

  • Zimmer® Zirconia Ceramic Femoral Head
  • Submitted by: .

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

  • Prepared by:
    Karen Cain Regulatory Affairs Specialist

  • Date: .
    December 21, 1995

  • Trade Name: .
    Zimmer® Zirconia Ceramic Femoral Head

  • Classification Name: .
    Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, 21 CFR 888.3353

  • Predicate Devices:

    • Zimmer® Zirconia Ceramic Femoral Heads, 22 through 28 mm -
  • Device Description: .

The Zimmer Zirconia Ceramic Femoral Head is made from yttria stabilized zirconia oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy, and aluminum oxide ceramic femoral heads. The Zimmer Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zimmer Zirconia Ceramic

83

1

Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.

The prosthesis is supplied in 22, 26, and 28 mm diameters and a variety of neck lengths.

  • Intended Use:
    The Zimmer Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

  • Comparison to Predicate Devices:
    The Zimmer Zirconia Ceramic Femoral Head is substantially equivalent to the femoral heads listed above as predicate devices. Each is designed to function as the modular femoral head component of a total hip prosthesis, is impacted onto the proximal taper of a femoral stem at the time of surgery, and articulates upon the UHMWPE-bearing surface of an acetabular component.

The Zimmer Zirconia Ceramic Femoral Head and the Zimmer Femoral Head for tapered neck provide the same size range (22, 26, and 28 mm diameters) and support the same type of taper for impaction upon the femoral stem component. The Zimmer Zirconia Ceramic Femoral Head and the Zimmer Ceramic Femoral Head (28 and 32 mm diameters) provide a 28 mm diameter head component, support the same type of taper for impaction upon the femoral stem component, and are made from ceramic materials. The Zimmer Zirconia Ceramic Femoral Head and the Richards and Biomet Zirconia Ceramic Femoral Heads provide similar size ranges and support similar tapers for impaction upon the femoral stem component. The material from which they are made is the same: zirconium oxide ceramic.

  • Clinical and Nonclinical Data
    Ceramic materials have been successfully used in orthopaedic applications for

2

approximately 20 years. These materials exhibit excellent resistance to corrosion and wear and are highly biocompatible. The yttria stabilized zirconium oxide from which the Zimmer Zirconia Ceramic Head is made has limited clinical history. Although mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates, the total amount of particulate produced remains undetermined. Because of limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing.

RA10505K.RP