VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS

K050222 · Biomet, Inc. · MBH · Aug 16, 2005 · Orthopedic

Device Facts

• Record ID: K050222
• Device Name: VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
• Applicant: Biomet, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or posttraumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated components and all polyethylene patellar components are indicated for cemented application only.

Device Story

Vanguard™ Anterior Stabilized Tibial Bearings are knee prosthesis components designed to provide increased anterior and posterior stabilization in the knee joint. Used in conjunction with Vanguard™ CR femoral components and tibial tray components, as well as commercially available Biomet patella buttons. The device replaces articular portions of the knee joint. Intended for surgical implantation by orthopedic surgeons to address joint pain, disability, or deformity. The device functions as a mechanical bearing surface to restore joint kinematics and stability, benefiting patients by alleviating pain and improving joint function following arthritis or failed prior procedures.

Clinical Evidence

No clinical data was necessary to support the claim of substantial equivalence; bench testing only.

Technological Characteristics

Knee prosthesis components; metal/polymer construction. Designed for patellofemorotibial replacement. Compatible with cemented and uncemented (porous-coated) fixation methods. Mechanical bearing design.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis (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. Porous-coated components allow cemented or uncemented fixation; non-coated and all-polyethylene patellar components are for cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Maxim Accel (Vanguard™) CR – Lipped Tibial Bearings (K023546)

Submission Summary (Full Text)

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K 05 0222

AUG 1 6 2005

BIOMET

## 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>Warsaw, IN 46582<br>FDA Registration # 1825034 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, IN 46581-0587<br>Telephone: [phone] Ext. 1568<br>Fax: [phone] |
| Proprietary Name: | Vanguard™ Anterior Stabilized Tibial Bearings. |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained<br>cemented prosthesis (§888.3560).<br>Knee joint, patellofemorotibial, metal/polymer porous coated uncemented<br>prosthesis (§888.3565). |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim Accel (Vanguard™) CR – Lipped Tibial Bearings – K023546

The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description: Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.

## Intended Use:

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

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

.

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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I·AX 574.267.8137

E-MAIL [e-mail]

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KOS0222

p.2/2

Femoral components and tibial tray components with porous coating are indicated for Femoral components and trail tray components with percused (Interlok") devices
cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
and all polyethylene patellar components are indicated for cemented application only.

Summary of Technologies: The Vanguard™ Anterior Stabilized Tibial Bearings have the same intended Summary of Technologies: The Vanguard™ Anterior Stablined Trical Pour Maring on
use, are made of the same materials and have the same or similar design and sizing as the pre bearings.

Risk analysis has demonstrated equivalence between the modified and predicate Non-Clinical Testing: devices.

No clinical testing was necessary to support the claim of substantial equivalence. Clinical Testing:

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2005

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. . . . . P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K050222

KV50222 Regulation Number: 21 CFR 888.3560, 21 CFR 888.3565 Regulation Name: Zr CFR 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 cemented prosthesis, Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II

Product Code: JWH, MBH Dated: July 22, 2005 Received: July 26, 2005

Dear Mr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to regars attent date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in easonance with the provisions of the Federal Food, Drug, devices mat have been recure approval of a premarket approval application (PMA). and Costicule rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the simment of the prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassified (600 a00 royals. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dr. Bratian that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the Her Frequirements, and manufacturing practice requirements as set CI K Part 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by ovisions (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) This letter will anow you to begin manxeing of substantial equivalence of your device to a legally premarket notification: The PDF intembers of the more 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 If you uesn't specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Colliact the Office of Complance an (21 notification" (21CFR Part 807.97). You may obtain Misblanding of reference to premains on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octiser http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smectry, Joan,

Mark N. Melkerson Acting 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)__K050222

Device Name: Vanguard™ Anterior Stabilized Tibial Bearings

Indications For Use:

- 1. Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic r annut and Gioone or more compartments are involved;
- arthritis where arus, valgus or posttraumatic deformity; 2.

... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

- correction of varias, vargus of postfaultatio decommy, arthrodesis, or failure of previous joint 3. replacement procedure.
Femoral components and tibial tray components with porous coating are indicated for cemented and Femoral components and thial tray components with porcus couldness and all polyethylene patellar ancements are indicated for cemented application only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use_ (Per 21 CFR 807 Subpart C)

______________________________________________________________________________________________________________________________________________________________________________

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
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| 510(k) Number | K050222 |