130 MODIFIED INTEGRAL FEMORAL COMPONENT

K984408 · Biomet, Inc. · LPH · Feb 12, 1999 · Orthopedic

Device Facts

• Record ID: K984408
• Device Name: 130 MODIFIED INTEGRAL FEMORAL COMPONENT
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 130° Modified Integral Femoral Components are intended for use in cases with a diagnosis of: - non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis a) - b) rheumatoid arthritis - non-union, femoral neck, and trochanteric fractures of the proximal femur with head c) involvement. - correction of functional deformities d) - revisions of previously failed surgeries and treatments e) The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.

Device Story

Forged titanium femoral stem implant; modular head taper-fit at surgery; designed for press-fit or cemented application in total hip arthroplasty. Modification of standard Integral femoral component involves inferior/medial trunion shift and 10° rotation, resulting in 130° neck angle (vs 140° standard) to improve joint stability via soft tissue tension. Features duck-bill collar for stability and reduced proximal profile. Used by orthopedic surgeons in clinical settings for hip replacement. Benefits include improved joint stability and anatomical fit.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Forged titanium stem; modular head taper-fit; duck-bill collar; 130° neck angle; uncemented (porous) or cemented application; single-use implant.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, proximal femur fractures (non-union, femoral neck, trochanteric with head involvement), functional deformities, or requiring revision of failed surgeries.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Integral Total Hip System (Biomet, Inc.) (K921225)
• Omni-Fit (Osteonics) (K940715)
• Natural Hip (Intermedics (Sulzer) Orthopaedics) (K920955)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular box. To the right of the word "BIOMET" is the word "INC" written vertically. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a serif font. Above the logo is the number K984408.

## SUMMARY OF SAFETY AND EFFECTIVENESS

Biomet. Inc SPONSOR:

130° Integral Modified Femoral Component DEVICE:

## CLASSIFICATION NAME:

- Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3558)

- Prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350)

INTENDED USE: The 130° Modified Integral Femoral Components are intended for use in cases with a diagnosis of:

- non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis a)
- b) rheumatoid arthritis
- non-union, femoral neck, and trochanteric fractures of the proximal femur with head c) involvement.
- correction of functional deformities d)
- revisions of previously failed surgeries and treatments e)

The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.

DEVICE DESCRIPTION: The device is composed of a forged titanium stem, which is designed to articulate with any commercially available acetabular component. The device is a modification of Biomet's standard Integral femoral component in that the trunion has been moved inferiorly, medially and rotated 10°, This results in a 130° neck angle as opposed to the standard 140° neck angle. Advantages of a reduced neck angle include potential increased joint stablity by improving soft tissue tension. The remainder of the stem is identical to that of the Biomet's standard Integral stems. The device features a duck-bill collar to provide implant stablity. The modified device has a reduced proximal profile. The device utilizes a modular head that is taper-fit on to the stem at the time of surgery.

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 | Deformity of the joint | Bone fracture | Hematoma |
|-----------------------------|------------------------|---------------------|--------------|
| Implant loosening/migration | Delayed wound healing | Blood vessel damage | Infection |
| Breakdown of porous surface | Soft tissue imbalance | Metal sensitivity | Nerve damage |
| Cardiovascular disorders | Tissue growth failure | Excessive wear | Dislocation |

SUBSTANTIAL EQUIVALENCE: The 130° Degree Integral Modified Femoral Component is substantially equivalent to most femoral devices on the market in overall design and intended function. Predicate devices include:

| Integral Total Hip System (Biomet, Inc.) | K921225 |
|-------------------------------------------------|------------|
| Omni-Fit (Osteonics) | K940715(?) |
| Natural Hip (Intermedics (Sulzer) Orthopaedics) | K920955 |

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

1

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

K984408 Re: 130º Modified Integral Femoral Components Trade Name: Requlatory Class: II Product Codes: LPH and JDI Dated: December 7, 1998 December 9, 1998 Received:

Dear Ms. Beres:

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 aqainst 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 In addition, FDA may publish further announcements action. 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. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA described in your sia (i) equivalence of your device to a legally finding of Substancial equitation a classification for your marketed predicate device rusalesice 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 victo diagnobels at [phone]. Additionally, for questions on compriation and advertising of your device, please contact che Dffice of Compliance at [phone]. Also, please note the orrios or compatied, "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,

Celta M. Witten, Ph.D., M.D.

Ph.D., M.D. Celra M. Witten, 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: 130° Modified Integral Femoral Components

Indications For Use:

- a) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b) rheumatoid arthritis
- c) non-union, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
- d) correction of functional deformities
- e) revisions of previously failed surgeries and treatments

The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984408

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use No
(Optional Format 1-2-96)