OSTEONICS X CEMENTED HIP STEM SERIES

K983226 · Osteonics Corp. · JDI · Dec 4, 1998 · Orthopedic

Device Facts

• Record ID: K983226
• Device Name: OSTEONICS X CEMENTED HIP STEM SERIES
• Applicant: Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® X Cemented Hip Stem Series are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® X Cemented Hip Stem Series are intended to provide a variety of options as a means for the Orthopaedic Surgeon to obtain an implant-to-patient match designed to provide reproducible cemented hip arthroplasty when used in conjunction with the Osteonics® Femoral Bearings with C-Taper geometry specified in this submission.

Device Story

Cemented hip stem prosthesis; used in total, hemi-, or bipolar hip arthroplasty. Implanted by orthopaedic surgeons in clinical settings. Device provides structural support for femoral component of hip joint; requires use with Osteonics Femoral Bearings with C-Taper geometry. Implant-to-patient match achieved through variety of sizes and neck angles. Benefits include reproducible cemented hip arthroplasty for patients with disabling joint disease or fractures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: ASTM F-799 Cobalt chromium alloy. Design: Cemented hip stems with 127 or 132-degree neck angles. Features: Satin finish, forged proximal centralizer, distal flutes (Omnifit-X/Plus), or distal hole for cement spacer (ODC-X/Plus). Sizes 4-11. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring Total Hip, 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 hip procedures, salvage of failed total hip arthroplasty, or clinical conditions where alternative reconstruction is less likely to succeed. Contraindicated for patients requiring acetabular bone cement when conservative acetabular procedures are indicated.

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®-X Cemented Hip Stem
• Osteonics® Omnifit®-X Plus Cemented Hip Stems
• Osteonics® Omnifit® Plus Hip Stems
• Osteonics® Omnifit®-C Hip Stems
• Osteonics® ODC™-X Cemented Hip Stems
• Osteonics® ODC™-X Plus Cemented Hip Stems
• Osteonics® ODC™ Hip Stems
• Osteonics® ODC™ Plus Hip Stems

Submission Summary (Full Text)

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

## Submission Information:

DEC 4 1998 -

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Osteonics Corporation<br>59 Route 17<br>Allendale NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Marybeth Naughton<br>Regulatory Affairs Team Member |
| Date of Summary Preparation: | September 14, 1998 |
| Device Identification | |
| Proprietary Name: | Osteonics® X Cemented Hip Stem<br>Series |
| Common Name: | Artificial Hip Component |
| Classification Name/Reference: | Hip Joint, Metal/Polymer,<br>Semi-constrained, Cemented<br>Prosthesis<br>21 CFR §888.3350 |

## Predicate Device Identification:

The Osteonics® X Cemented Hip Stem Series are substantially equivalent to the following predicate devices: The Osteonics® Omnifit®-X Cemented Hip Stem and the Osteonics® Omnifit®-X Plus Cemented Hip Stems are substantially equivalent to the Osteonics® Omnifit® Plus Hip Stems and the Osteonics® Omnifit®-C Hip Stems and the Osteonics® ODC™-X Cemented Hip Stems and the Osteonics® ODC™-X Plus Cemented Hip Stems are substantially equivalent to the Osteonics® ODC™ Hip Stems and the Osteonics® ODC™ Plus Hip Stems.

# Description of Devices:

The Osteonics® X Cemented Hip Stem Series of cemented hip stems designed to meet requirements of a wide range of patients requiring cemented hip arthroplasty. All components are manufactured from ASTM F-799 Cobalt chromium alloy. The Osteonics® Omnifit®-X Cemented Hip Stems and the Osteonics® Omnifit®-X Plus Cemented Hip Stems

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have a 132 degree neck and 127 degree neck angle respectively. They employ a satin was and finish, polished neck, forged proximal centralizer, and distal flutes and are available in sizes 4 through 11. The Osteonics® ODC™-X Cemented Hip Stems and the Osteonics® ODC™-X Plus Cemented Hip Stems have a 132 degree neck angle and 127 degree neck angle respectively. They employ a satin finish, forged proximal centralizer, and distal hole for use with optional cement spacer and are available in sizes 5 through 11.

## Intended Use:

The Osteonics® X Cemented Hip Stem Series are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® X Cemented Hip Stem Series are intended to provide a variety of options as a means for the Orthopaedic Surgeon to obtain an implant-to-patient match designed to provide reproducible cemented hip arthroplasty when used in conjunction with the Osteonics® Femoral Bearings with C-Taper geometry specified in this submission.

### Statement of Technological Comparison:

The design, materials, and intended use of the Osteonics® X Cemented Hip Stem Series are substantially equivalent in design, materials and intended use to the predicate devices. The Osteonics® Omnifit®-X Cemented Hip Stem and the Osteonics® Omnifit®-X Plus Cemented Hip Stems are substantially equivalent to the Osteonics® Omnifit® Plus Hip Stems and the Osteonics® Omnifit®-C Hip Stems and the Osteonics® ODC™-X Cemented Hip Stems and the Osteonics® ODC™-X Plus Cemented Hip Stems are substantially equivalent to the Osteonics® ODC™ Hip Stems and the Osteonics® ODC™ Plus Hip Stems.

#### Performance Data:

Performance data for the Osteonics® X Cemented Hip Stem Series provided in this submission demonstrates the substantial equivalence to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 DEC

> Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K983226 Osteonics® X Cemented Hip Stem Series Regulatory Class: II Product Code: JDI Dated: September 14, 1998 Received: September 15, 1998

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Elizabeth A. Staub

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if Known):

Device Name: Osteonics® X Cemented Hip StemSeries

# Indications For Use:

The Osteonics® X Cemented Hip Stems Series are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® X Cemented Hip Stem Series are intended to provide a variety of options as a means for the Orthopaedic Surgeon to obtain an implant-to-patient match designed to provide reproducible cemented hip arthroplasty when used in conjunction with the Osteonics® Femoral Bearings with C-Taper geometry specified in this submission.

# 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, theumatoid 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|-------------------------------------------|---|
| OROver-The-Counter Use | |
| (per21CFR 801.109(Optional Format 1-2-96) | |

| (Division Sign-Off) | |
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Division of General Restorative Devices K983226

| 510(k) Number | |
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