OSTEONICS OFFSET HIP STEMS

K954598 · Osteonics Corp. · JDI · Apr 4, 1996 · Orthopedic

Device Facts

• Record ID: K954598
• Device Name: OSTEONICS OFFSET HIP STEMS
• Applicant: Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Offset Hip Stems are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications. The specific intended uses of the Osteonics® Offset Hip Stems include the following: Indications For use as a Bipolar or Hemi-Hip Replacement: - Femoral head/neck fractures or non-unions. - Aseptic necrosis of the femoral head. - Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other considerations for use as a Bipolar or Hemi-Hip Replacement: - Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. - Salvage of failed total hip arthroplasty. For use as a Total Hip Replacement: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Story

Forged cobalt chromium alloy femoral hip stems; implanted into prepared femurs during total, hemi-, or bipolar hip arthroplasty. Used in cemented or cementless applications. Design features include proportional sizing, proximal grit-blasting, Osteonics® C-Taper femoral neck, 127° neck angle, and enhanced offset. Available in collared and collarless versions. Implanted by orthopedic surgeons in clinical settings. Provides structural support for hip joint replacement; restores joint function and mobility; alleviates pain from degenerative or traumatic joint disease.

Clinical Evidence

Bench testing only. Fatigue testing results from predicate hip stem series were used to qualify the performance characteristics of the subject device.

Technological Characteristics

Forged cobalt chromium alloy (ASTM F-799). Features: proximal grit-blasting, Osteonics® C-Taper femoral neck, 127° neck angle, enhanced offset. Available in collared/collarless versions. Distal hole for optional cement spacer. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring total, hemi-, or bipolar hip replacement due to femoral head/neck fractures, non-unions, aseptic necrosis, or arthritis (osteo-, rheumatoid, post-traumatic). Also indicated for revision of failed procedures or salvage of failed total hip arthroplasty.

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

• Osteonics® Omnifit® Plus Cemented Hip Stems
• Osteonics® ODC Hip Stems
• Osteonics® Restoration Cemented Hip Stems

Submission Summary (Full Text)

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K954598

Osteonics® Offset Hip Stem Series

510(k) Summary

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness for the Osteonics® Offset Hip Stem Series

## Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
| --- | --- |
| Contact Person: | Terry Jarosz
Regulatory Affairs Specialist |
| Date of Summary Preparation: | October 2, 1995 |

## Device Identification

| Proprietary Name: | Osteonics® Offset Hip Stem Series |
| --- | --- |
| Common Name: | Artificial Hip Component |
| Classification Name and Reference: | Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis
21 CFR §888.3350 |

## Predicate Device Identification

The Osteonics® Offset Hip Stems are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® Omnifit® Plus Cemented Hip Stems - Osteonics Corp.
- Osteonics® ODC Hip Stems - Osteonics Corp.
- Osteonics® Restoration Cemented Hip Stems - Osteonics Corp.

## Device Description

The Osteonics® Offset Hip Stems are intended to be placed within the prepared femurs of patients requiring total or hemi- hip arthroplasty. These hip stems may be implanted either with or without the use of bone cement. The Osteonics® Offset Hip Stems are forged from cobalt chromium alloy, and are characterized by proportional stem sizing, proximal projected area, proximal grit-blasting, Osteonics® C-Taper femoral neck, enhanced offset, and a 127" neck angle. The stems are available in collared and collarless versions, and in a full range of sizes.

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Osteonics® Offset Hip Stem Series
510(k) Summary

# Intended Use:

The Osteonics® Offset Hip Stems are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications.

The specific intended uses of the Osteonics® Offset Hip Stems include the following:

## Indications

### For use as a Bipolar or Hemi-Hip Replacement:

- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

### Other considerations for use as a Bipolar or Hemi-Hip Replacement:

- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.

### For use as a Total Hip Replacement:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

# Statement of Technological Comparison:

The subject devices, essentially, are the predicate Osteonics® ODC Femoral Stems from the collar area down (except that the subject devices are made from forged rather than from cast CoCr alloy), and the predicate Osteonics® Omnifit® Plus Cemented Hip Stems from the collar area up. A more detailed comparison between the subject and predicate devices, in terms of design, materials and intended uses, follows.

### Design:

As previously stated, the subject devices are nearly identical in design - from the collar area and up - to the predicate Osteonics® Omnifit® Plus Cemented Hip Stems. Both hip stem series feature Osteonics® C-Taper neck, a 127° neck angle, and extended head offsets.

Distal to the collar location, the subject hip stems are identical in design to the predicate Osteonics® ODC Femoral Stems. Both the subject and the predicate hip stem series are grit-blasted proximally (but distal to the collar). Both the predicate and the subject hip stem series share the same dimensions distal to the collar location. Both hip stem series feature a distal hole for use with an optional cement spacer.

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Osteonics® Offset Hip Stem Series
510(k) Summary

## Materials:

The subject devices, like the predicate Osteonics® Omnifit® Plus Cemented Hip Stems, are forged from ASTM F-799 cobalt chromium alloy.

## Intended Use:

The subject devices share the same indications for use as one or more of the predicate devices identified above. In addition, both the subject devices and the predicate Osteonics® ODC Hip Stems are intended for cemented and cementless indications.

## Performance Data:

Comparison of the subject hip stem series with a predicate hip stem series demonstrated that fatigue testing results for the predicate hip stem series can be relied upon to qualify the performance characteristics of the subject hip stem series.

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