ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

K955877 · Zimmer, Inc. · LZO · Oct 8, 1996 · Orthopedic

Device Facts

• Record ID: K955877
• Device Name: ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Oct 8, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Modular femoral head component for total hip arthroplasty; manufactured from yttria-stabilized zirconia oxide (ZrO2) ceramic. Designed for impaction onto tapered neck of Tivanium (Ti-6Al-4V) or Zimaloy (Co-Cr-Mo) femoral stems; articulates against UHMWPE acetabular component. Available in 22, 26, and 28 mm diameters with various neck lengths. Used in clinical settings by orthopedic surgeons during hip replacement procedures. Provides alternative to cobalt-chrome or aluminum oxide ceramic heads; offers corrosion resistance and biocompatibility. Clinical benefit derived from restoring hip function in patients with severe joint pathology.

Clinical Evidence

No clinical data provided. Device relies on mechanical testing demonstrating low particulate production when articulating with polyethylene acetabular cups. Long-term biological effects of particulates remain unknown due to limited clinical/preclinical experience; clinical investigation is ongoing.

Technological Characteristics

Material: Yttria-stabilized zirconium oxide (ZrO2) ceramic. Form factor: Modular femoral head, 22-28 mm diameters. Interface: Tapered neck for impaction onto femoral stem. Articulation: UHMWPE acetabular component. Biocompatible, corrosion-resistant.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability from previous fusion, failed endoprostheses/total hip components, or acute neck fractures.

Regulatory Classification

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.

Predicate Devices

• Zimmer Zirconia Ceramic Femoral Heads, 22 through 28 mm

Reference Devices

• Richards Zirconia Ceramic Femoral Heads
• Biomet Zirconia Ceramic Femoral Heads

Submission Summary (Full Text)

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zimmer

OCT - 8 1996

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

# K955877
## 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

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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

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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

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