ALTRA PRESS-FIT HIP SYSTEM

K063002 · Biomet Manufacturing Corp · KWA · Oct 31, 2006 · Orthopedic

Device Facts

• Record ID: K063002
• Device Name: ALTRA PRESS-FIT HIP SYSTEM
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Altra™ Press-Fit Hip System is intended for uncemented use only.

Device Story

Altra™ Press-Fit Hip System is a femoral hip stem prosthesis; manufactured from Ti-6Al-4V titanium alloy; designed for uncemented fixation in total hip arthroplasty. Device implanted by orthopedic surgeons in clinical/hospital settings to replace diseased or damaged femoral head/neck. System utilizes Biomet Type I Taper for component connection. Provides structural support for hip joint; restores joint function; alleviates pain associated with degenerative conditions or fractures. Mechanical performance verified via bench testing.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical bench testing.

Technological Characteristics

Material: Ti-6Al-4V titanium alloy (ASTM F-136). Design: Hip stem for uncemented use. Connection: Biomet Type I Taper. No software or electronic components.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring surgical intervention, and for revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Fine Grain Cast Cobalt Chromium Hip Stem (K953925)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Above the word, there is a handwritten alphanumeric string "K063002". The word "BIOMET" is the main focus of the image, with the alphanumeric string appearing as a secondary element.

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OCT 3 ] 2006

#### 510(k) Summary

| Preparation Date: | September 29, 2006 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>Warsaw, Indiana 46582 |
| Contact Person: | Gary Baker M.S. RAC<br>Regulatory Specialist<br>Biomet Manufacturing Corp.<br>Tel: [phone] Extension 1568<br>Fax: [phone]<br>e-mail: [e-mail] |
| Proprietary Name: | Altra™ Press-Fit Hip System |

Common Name: Common Hip Stem

# Classification Code(s)/Name(s):

LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis §888.3353.

KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis §888.3330

KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis \$888.3310

JDL - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis \$888.3320

JDI - Hip joint metal/polymer semi-constrained cemented prosthesis §888.3350 MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis \$888.3353.

MEH – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis §888.3353.

LPH - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis \$888.3358

KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 888.3360.

LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 888.3360.

KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis §888.3390

| MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581 0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive<br>Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| E-MAIL | [e-mail] |

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# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

063002

Fine Grain Cast Cobalt Chromium Hip Stem - K953925

## Device Description:

The Altra™ Press-Fit Hip System consists of a hip stem made from Ti-6AJ-4V titanium alloy conforming to ASTM F-136.

#### Intended Use:

Indications for Use:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

The Altra™ Press-Fit Hip System is intended for uncemented use only.

#### Summary of Technologies:

The Altra™ Press-Fit Hip System incorporates a similar design with similar technological features as the predicate hip stem. It has the same intended use, indications for use, and utilizes the same Biomet Type I Taper as the predicate stems. These similarities demonstrate that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate hip stem.

#### Non-Clinical Testing:

Mechanical testing demonstrated that the Altra™ Press-Fit Hip System is substantially equivalent to the predicate device.

## Clinical Testing:

Clinical testing was not conducted in support of substantial equivalence.

All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 3 1 2006

Biomet Manufacturing Corp. % Mr. Gary Baker, M.S., RAC 56 East Bell Drive Warsaw, Indiana 46582

Re: K063002

Trade/Device Name: Altra Press-Fit Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Codes: KWA, JDL, LZO, KWZ, JDI, MAY, MEH, LPH, KWL, LWJ, KWY Dated: September 29, 2006 Received: October 2, 2006

Dear Mr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary Baker, M.S., RAC

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for Delbert

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO6 3002

## Indications for Use

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2. Rheumatoid arthritis
- 3. Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable using other techniques
- 5. Revision of previously failed total hip arthroplasty.

The Altra™ Press-Fit Hip System is intended for uncemented use only.

Prescription Use _ YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P.O. Thung
Division Sign Off

(Division Sign-Off Division of General, Restorative, and Neurological Livices

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**510(k) Number** L, 063006

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