HERITAGE HIP SYSTEM

K963109 · Zimmer, Inc. · JDI · Jan 9, 1997 · Orthopedic

Device Facts

• Record ID: K963109
• Device Name: HERITAGE HIP SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jan 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures. The indications for total hip arthroplasty are: 1. 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. 2. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. 3. Patients suffering from disability due to previous fusion. 4. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. 5. Patients with acute femoral neck fractures. The indications for hemi-hip arthroplasty are: 1. Fracture dislocation of the hip. 2. Elderly, debilitated patients when a total hip replacement is contraindicated. 3. Irreducible fractures in which adequate fixation cannot be obtained. 4. Certain high subcapital fractures and comminuted femoral fractures in the aged. 5. Nonunion of femoral neck fractures. 6. Secondary avascular necrosis of the femoral head. 7. Pathological fractures of the femoral neck. 8. Osteoarthritis in which the femoral head is primarily affected.

Device Story

Modular cemented femoral hip prosthesis; forged high-strength Zimaloy Alloy; proximal collar; anterior/posterior flats; semispherical medial radius; distal hole for optional centralizer; 132-degree neck angle; Morse taper for modular femoral heads; smoothly polished surface. Used in clinical setting by orthopedic surgeons during total or hemi-hip arthroplasty. Provides structural replacement for femoral head/neck; restores joint function; reduces pain; improves mobility. Five primary sizes; CDH and valgus variants; three revision stems.

Clinical Evidence

Bench testing only. Fatigue testing performed on proximal and distal sections of stem sizes. All samples survived 10,000,000 cycles at specified loads, meeting predetermined design criteria.

Technological Characteristics

Material: Forged high-strength Zimaloy Alloy. Design: Modular cemented femoral stem; Morse taper connection; 132-degree neck angle; polished surface finish. Sizes: Five primary, CDH/valgus variants, three revision stems. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring cemented total or hemi-hip arthroplasty due to severe hip pain/disability from arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, failed endoprostheses, acute femoral neck fractures, fracture dislocation, or pathological fractures. Applicable to elderly/debilitated patients where total hip replacement is contraindicated.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Charnley-Type Total Hip Prosthesis
• ZCH Hip Prosthesis
• Longevity™ Monoblock Hip Prosthesis

Submission Summary (Full Text)

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JAN - 9 1997

Summary of Safety and Effectiveness
Heritage™ Hip Prosthesis System

K963109

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

- Prepared by:
Lynnette Whitaker, RAC
Manager
Regulatory Affairs
219-372-4561

- Date:
August 8, 1996

- Trade Name:
Heritage™ Hip Prosthesis System

- Common Name:
Femoral Hip Prosthesis

- Classification Name:
Hip Joint Metal/Polymer Semicconstrained Cemented Prosthesis, 21 CFR 888.3350

- Predicate Devices:
Charnley-Type Total Hip Prosthesis
ZCH Hip Prosthesis
Longevity™ Monoblock Hip Prosthesis

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A Bristol-Myers Squibb Company

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- Device Description:

The Heritage Hip Prosthesis is a modular cemented femoral hip prosthesis manufactured from forged high-strength Zimaloy Alloy. The design of the stem includes a small proximal collar with flats included on the anterior and posterior sides of the stem. The medial surface of the stem is designed with a semispherical radius. The stems also have a distal hole for use with an optional distal centralizer. The angle of the stem neck is 132 degrees for greater offset and increased range of motion. The stem is designed with a Morse taper for use with modular femoral heads. The outer surface of the stems are smoothly polished for cemented use. Five primary stem sizes are available and described as sizes one through five. Two stems, CDH and valgus, are available with slightly less offset neck lengths as needed. Three revision stems are available.

- Intended Use:

The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures.

The indications for total hip arthroplasty are:

1. 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.

2. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.

3. Patients suffering from disability due to previous fusion.

4. Patients with previously failed endoprostheses and/or total hip components in the affected extremity.

5. Patients with acute femoral neck fractures.

The indications for hemi-hip arthroplasty are:

1. Fracture dislocation of the hip.

2. Elderly, debilitated patients when a total hip replacement is contraindicated.

3. Irreducible fractures in which adequate fixation cannot be obtained.

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4. Certain high subcapital fractures and comminuted femoral fractures in the aged.
5. Nonunion of femoral neck fractures.
6. Secondary avascular necrosis of the femoral head.
7. Pathological fractures of the femoral neck.
8. Osteoarthritis in which the femoral head is primarily affected.

- Performance Data:

Fatigue testing was performed on the proximal section of two stem sizes and on the distal section of another stem. All stems survived at the specified load for 10,000,000 cycles. The testing demonstrated that the stems met the predetermined design criteria and that the stems can be expected to perform similarly to other stems tested to the same criteria.

RA08601K.510

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