SUPER EON PLUS FEMORAL STEMS

K020989 · Howmedica Osteonics Corp. · JDI · Apr 26, 2002 · Orthopedic

Device Facts

• Record ID: K020989
• Device Name: SUPER EON PLUS FEMORAL STEMS
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.

Device Story

Super EON Plus Femoral Stems are orthopedic implants for primary and revision total or hemi-hip arthroplasty. Fabricated from forged cobalt chromium alloy; designed for cemented applications. Available in 127-degree and 132-degree neck angles; sizes #4 through #10. Device functions as a structural replacement for the femoral component of the hip joint. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical support and joint articulation; intended to restore hip function and alleviate pain in patients with degenerative or traumatic joint disease. Design modification of predicate Omnifit EON Femoral Stems to expand product line.

Clinical Evidence

Bench testing only. Fatigue testing was performed to compare the body and neck strength of the subject Super EON Plus femoral stems against the predicate Omnifit EON femoral stems, demonstrating comparable performance.

Technological Characteristics

Material: forged cobalt chromium alloy (ASTM F 799). Application: cemented hip arthroplasty. Design: femoral stem with 127-degree and 132-degree neck angles, sizes #4-10. Mechanical device; no software, electronics, or energy source.

Indications for Use

Indicated for patients requiring primary or revision total or hemi-hip arthroplasty. Hemi-hip indications: femoral head/neck fractures or non-unions, aseptic necrosis of femoral head, hip arthritis (osteo-, rheumatoid, post-traumatic) with minimal acetabular involvement, pathological conditions favoring avoidance of acetabular bone cement, or salvage of failed total hip arthroplasty. Total hip indications: painful, disabling hip joint disease (degenerative, rheumatoid, post-traumatic arthritis, or late-stage avascular necrosis) or revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedures where alternative treatments are less likely to achieve satisfactory results.

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

• Omnifit EON Femoral Stems (K983226)

Submission Summary (Full Text)

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| | SUBJECT DEVICE | PREDICATE DEVICE |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Proprietary Name: | Super EON Plus Femoral Stems | Omnifit EON Femoral Stems |
| Common Name: | Artificial Hip Component | Artificial Hip Component |
| Classification Name and<br>Reference: | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI | (87) JDI |
| For Information contact: | Jennifer A. Daudelin. Regulatory Affairs<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>[phone]<br>Fax: [phone]<br>Email: [e-mail] | |

Special 510(k) Summary – SUPER EON PLUS FEMORAL STEMS

# Device Description

This Special 510(k) submission is intended to address a design modification to the Omnifit EON Femoral Stems. This modification will create the new subject device, hereby referred to as the Super EON Plus femoral stems to expand the product line. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The subject device is fabricated from forged cobalt chromium alloy conforming to ASTM F 799. The Super EON Plus femoral stems are available in 127 degree and 132 degree neck angles and range in size from size #4 through size #10.

## Predicate Device

The predicate Omnifit EON femoral stems were found substantially equivalent via the 510(k) process in K983226.

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Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems.

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### Intended Use

Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing service to the individual and the family. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.

Public Health Service

APR 26.2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Associate Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677

Re: K020989

> Trade Name: Super EON Plus Femoral Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal / Polymer / Semi-Constrained / Cemented Prosthesis Regulatory Class: II Product Code: JDI Dated: March 26, 2002 Received: March 27, 2002

Dear Ms. Daudelin:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 regulation may result in regulatory 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. Jennifer A. Daudelin

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 regulation (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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

b. Mark N. Milkman

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

Enclosure

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#### Indications for Use

page lot

510(k) Number (if known):

Device Name: Super EON Plus Femoral Stems

Indications for Use:

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;
- Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
- Salvage of failed total hip arthroplasty. .

Indications for use as part of a Total Hip Replacement include:

OR

- 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;
- Procedury, . are less likely to achieve satisfactory results.

Mark n millerson

(Division Sign-Of (Division of General, Restorative and Neurological Devices

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)