THE NEW BIO-MOORE ENDO HEADS

K984028 · Biomet, Inc. · KWL · Jan 19, 1999 · Orthopedic

Device Facts

• Record ID: K984028
• Device Name: THE NEW BIO-MOORE ENDO HEADS
• Applicant: Biomet, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Jan 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The New Bio-Moore Endo Heads is indicated for use in: - a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis - b.) rheumatoid arthritis - c.) revisions procedures where other devices or treatments have failed - d.) correction of functional deformities - e.) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement. The Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implantation.

Device Story

New Bio-Moore Endo Heads are modular hemiarthroplasty components designed to replace the femoral head while preserving the acetabulum. Device consists of a metal ball head used with taper inserts to adjust neck length, providing surgeons flexibility in the OR to ensure accurate fit. Intended for impaction onto press-fit or cemented femoral stems. Used in orthopedic surgery to treat degenerative joint disease, arthritis, and proximal femur fractures. Benefits include bone preservation and intraoperative customization of neck length. Single-use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Modular metal femoral head components designed for impaction on femoral stems. Features taper inserts for neck length adjustment. Single-use. Materials and specific ASTM standards not disclosed in provided text.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformities, failed prior treatments, or proximal femur fractures (non-unions, femoral neck, trochanteric) requiring hemiarthroplasty.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Unitrax V40 Modular Adaptor (K954077)
• Osteo Austin Moore Endoprostheis System (K974807)
• Prime Modular Endo Head (K962646)
• Opteon Unipolar Endoprosthesis (K960538)
• Ultima Unipolar head and Adapter Sleeves (K965156)
• Austin Moore Endoprosthesis (K845025)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 1 9 1999

DEVICE:

## 984028 SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR: | Biomet, Inc<br>P.O. Box 587<br>Airport Industrial Park<br>Warsaw, Indiana 46581-0587 |
|-----------------|--------------------------------------------------------------------------------------|
| CONTACT PERSON: | Tracy J. Bickel |

CLASSIFICATION NAME: Prosthesis hip, hemi, metal ball

INTENDED USE: The New Bio-Moore Endo Heads is indicated for use in:

- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
The New Bio-Moore Endo Heads

- b.) rheumatoid arthritis
- c.) revisions procedures where other devices or treatments have failed
- d.) correction of functional deformities
- e.) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement.

The Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implantation.

DEVICE DESCRIPTION: The New Bio-Moore Endo Heads are used as a hemi device and only replaces the head and not the acetubulum. The purpose is to preserve as much bone as possible. The heads allows for the use of taper inserts to vary the lengths of the neck which allows the surgeon greater flexibility in the OR. The taper inserts are assembled during surgery to insure an accurate fit.

POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of joint Tissue growth failure Delayed wound healing Metal sensitivity

Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation

{1}------------------------------------------------

SUBSTANTIAL EQUIVALNCE: The Bio-Moore Endo Heads are similar to all other devices on the market in terms of intended use and design.

Predicate devices include:

Unitrax V40 Modular Adaptor (Howmedica, Rutherford, NJ) 510(K) #K954077 Osteo Austin Moore Endoprostheis System (Osteonics , Allendale, NJ) 510(K) #K974807 Prime Modular Endo Head (Orthopaedic Innovations, Minneapolis, MN) 510(K) #K962646 Opteon Unipolar Endoprosthesis (Exactech, Gainesville, FL) 510(K) #K960538 Ultima Unipolar head and Adapter Sleeves (Johnson & Johnson, Raynham, MA) 510(K) #K965156 Austin Moore Endoprosthesis (Biomet, Warsaw, IN) 510(K) #K845025

00055

00055

{2}------------------------------------------------

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three flowing lines representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K984028 New Bio-Moore Endo Head Trade Name: Requlatory Class: II Product Code: KWL November 2, 1998 Dated: November 12, 1998 Received:

Dear Ms. Bickel:

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, 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. ਸ੍ਰੇ 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 Please note: concerning your device in the Federal Register. 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.

{3}------------------------------------------------

## Page 2 - Ms. Tracy J. Bickel

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,

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

Enclosure

{4}------------------------------------------------

Page / of /

510(K) NUMBER IF KNOWN: K984028
DEVICE NAME: The New Bio-Moore Endo Head

The indications for use are:

- a.) non-inflammatory degenerative joint disease, including avascular necrosis and osteoarthritis.
- b.) rheumatoid arthritis
- c.) correction of functional deformities
- d.) revision procedures where other devices or treatments have failed
- e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur with neck involvement

The New Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implants.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or Over the Counter-Use for (Optional Format 1-2-96)

00002

Division of General Restorative Devices
510(k) Number K98402