ECHO BI-METRIC PRESS-FIT STEMS

K070274 · Biomet Manufacturing Corp · KWA · Apr 3, 2007 · Orthopedic

Device Facts

• Record ID: K070274
• Device Name: ECHO BI-METRIC PRESS-FIT STEMS
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Apr 3, 2007
• 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 Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.

Device Story

Echo™ Bi-Metric® Press-Fit Stems are orthopedic hip implants designed for uncemented fixation in total hip arthroplasty. Device serves as femoral component in hip replacement surgery; implanted by orthopedic surgeons in clinical/hospital settings. Stems provide structural support and joint articulation interface for patients suffering from degenerative joint disease, rheumatoid arthritis, or femoral fractures. Device utilizes Biomet Type I Taper for modular head attachment. Clinical benefit includes restoration of hip joint function and mobility. Device is purely mechanical; no software or electronic components.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical laboratory testing.

Technological Characteristics

Material: Ti-6Al-4V (ASTM F-136). Coating: Porous Plasma Spray (ASTM F-1580). Design: Uncemented femoral hip stem with Biomet Type I Taper. Mechanical fixation.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), or those requiring 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

• Altra Press-Fit Hip Stem (K063002)

Submission Summary (Full Text)

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K070274 1 of 2

## 510(k) Summary

January 24, 2007 Preparation Date:

APR - 3 2007

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Susan Alexander

Echo™ Bi-Metric® Press-Fit Stems Proprietary Name:

Common Name: Hip Stem

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

LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)

KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabular component. prosthesis (21 CFR 6888.3330)

KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)

JDL - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (21 CFR §888.3320)

JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 6888,3350) MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)

MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)

LPH - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 6888.3358)

KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 8888.3360)

LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR \$888.3360)

KWY -- Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 6888.3390)

#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Altra Press-Fit Hip Stem K063002 Biomet Manufacturing Corp.

Device Description: The Echo™ Bi-Metric® Press-Fit Stems are hip stems made from Ti-6Al-4V conforming to ASTM F-136. Portions of the devices are coated with Porous Plasma Spray conforming to ASTM F-1580.

Image /page/0/Figure/23 description: The image shows contact information for a company, including mailing address, shipping address, office phone number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office phone number is 574.267.6639, the fax number is 574.267.8137, and the email address is [e-mail].

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## Indications for Use:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis 2.
- 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 Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.

Summary of Technologies: The Echo™ Bi-Metric® Press-Fit Stems incorporate a similar design with similar technological features as the predicate hip stems. They have the same intended use, indications for use, and utilize the same Biomet Type I Taper as the predicate stems. These similarities demonstrate that the Echo™ Bi-Metric® Press-Fit Stems are substantially equivalent to the predicate hip stems.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: Clinical testing was not required for the predicate devices. Therefore, this submission contains no clinical testing.

All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist Post Office Box 587 Warsaw, Indiana 46581

Re: K070274

Trade/Device Name: Echo™ Bi-Metric® Press Fit Stems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component, prosthesis Regulatory Class: III

APR - 3 2007

Product Code: KWA Dated: March 14, 2007 Received: March 15, 2007

Dear Ms. Alexander:

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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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/dsma/dsmamain.html

Sincerely yours,

Tarbay Buehno
for

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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# Indications for Use

510(k) Number (if known): _

Device Name: Echo™ Bi-Metric® Press Fit Stems

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 Echo™ Bi-Metric® Press-Fit Stems are 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)

Barbara Buchm

Division of General, Restorative. and Neurological Devices

510(k) Number k070274

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