VANGUARD SSK KNEE SYSTEM

K042757 · Biomet, Inc. · JWH · Feb 11, 2005 · Orthopedic

Device Facts

• Record ID: K042757
• Device Name: VANGUARD SSK KNEE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Vanguard™ SSK components are intended for cemented use only.

Device Story

Vanguard™ SSK Knee System consists of femoral components and tibial bearings; replaces articulating surfaces during knee replacement surgery. Used in clinical settings by orthopedic surgeons. Components implanted via cemented fixation. System restores joint function and alleviates pain in patients with degenerative or traumatic knee conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cemented semi-constrained polymer/metal/polymer knee prosthesis. Materials identical to predicate devices. Designed for cemented fixation.

Indications for Use

Indicated for patients with painful, disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments; patients requiring correction of varus, valgus, or posttraumatic deformity; and patients requiring revision of failed osteotomy, arthrodesis, or previous joint replacement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Maxim Accel (Vanguard) Knee System (K023546)
• Maximum Congruent Knee System (K9151332)

Submission Summary (Full Text)

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FEB 1 1 2005

K042757

### 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Phone: [phone]<br>FAX: [phone] |
| Proprietary Name: | Vanguard™ SSK Knee System |
| Common Name: | Knee prosthesis |
| Classification Name: | Cemented semi-constrained polymer / metal / polymer knee<br>prosthesis (21 CFR § 888.3560) |

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

Maxim Accel (Vanguard) Knee System - K023546 (Biomet Inc.) Maximum Congruent Knee System - K9151332 (Biomet Inc.)

Device Description: The Vanguard™ SSK Knee System is a series of femoral components and tibial bearings designed to replace the articulating surfaces during knee replacement surgery.

### Intended Use:

Indications for Use:

- 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- 2. Correction of varus, valgus, or posttraumatic deformity.
- 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Vanguard™ SSK components are intended for cemented use only.

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

통

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

트

OFFICE 574.267.6639

I·AX 574.267.8137

101

IE-MAIL [e-mail]

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Summary of Technologies: The Vanguard™ SSK Knee System components have the same intended use (knee joint replacement), the same functional characteristics (knee joint articulation), and are manufactured from the same materials as the predicate devices.

Non-Clinical Testing: The performance data indicated that the Vanguard™ SSK Knee System is substantially equivalent to the predicate devices for the uses indicated.

Clinical Testing: Clinical testing was not required for these components to support substantial equivalence.

102

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2005

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K042757 Trade/Device Name: Vanguard SSK Knee System Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: January 28, 2005 Received: January 31, 2005

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 (sec 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

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 I legally marketed predicate device results in a classification for your device and thus, permitts 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 (240) 276-_. 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,

Mark A. Millman

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

510(k) Number (IF KNOWN): K042757

Device Name: Vanguard™ SSK Knee System

Indications for Use:

| 1. | Painful and disabled knee joint resulting from osteoarthritis,<br>rheumatoid arthritis, traumatic arthritis where one or more<br>compartments are involved. |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Correction of varus, valgus, or posttraumatic deformity. |
| 3. | Correction or revision of unsuccessful osteotomy, arthrodesis, or<br>failure of previous joint replacement procedure. |

Vanguard™ SSK components are intended for cemented use only.

Prescription Use >> AND/OR (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number
K042757