VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS

K060303 · Biomet Manufacturing Corp · MBH · Mar 30, 2006 · Orthopedic

Device Facts

• Record ID: K060303
• Device Name: VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
• Applicant: Biomet Manufacturing Corp
• Product Code: MBH · Orthopedic
• Decision Date: Mar 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of: 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. The device is a single use implant.

Device Story

Vanguard™ PS Open Box Porous Femoral Component; orthopedic knee implant. Device features articulating surface identical to predicate Maxim® Accel (Vanguard™) PS Interlok® femoral components; porous-coated inner surface identical to cruciate retaining (CR) porous design. Implant used in total knee arthroplasty; surgical procedure performed by orthopedic surgeons in hospital setting. Device replaces damaged joint surfaces; restores joint function; corrects deformities. Single-use implant; intended for cemented or non-cemented fixation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by engineering justification and Finite Element Comparison.

Technological Characteristics

Porous-coated femoral knee prosthesis. Design features open box posterior stabilized (PS) configuration. Materials and design are identical to predicate devices. Intended for cemented or non-cemented fixation.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis; 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 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 Knee System (K023546)
• Non-Cemented Porous Coated Knees (K033489)

Submission Summary (Full Text)

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## 510(k) Summary

| Preparation Date: | February 2, 2006 | MAR 3 0 2006 |
|--------------------|-------------------------------------------------|--------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp. | |
| Contact Person: | Susan Alexander | |
| Proprietary Name: | Vanguard™ PS Open Box Porous Femoral Components | |
| Common Name: | Porous coated knee replacement components | |

Classification Name: Cemented semi-constrained polymer knee prosthesis [888.3560]; Crassinceren Namer

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System (K023546); Non-Cemented Porous Coated Knees (K033489)

Device Description: The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.

Intended Use: The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:

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

The device is a single use implant.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Sunning your Toonnorogram Components are similar to or identical to the predicate devices.

Non-Clinical Testing: To supplement previous testing, an engineering justification including a Finite Element Comparison was performed. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

MAILING ADDRESS 110. Box 587 Warsaw. IN 46581 0587

SHIPPING ADDRESS 56 E. Bell Drive Wars:is. IN 16552

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のFFにIC 574.267.66.39

FAX [phone]

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II:- MAII. bjonnet @ biomet com

All trademarks are property of Biomet with the exception of the following: Insall/Burstein II(@ is a trademark of Zimmer, Inc. Tyvek® is a trademark of E.I. dePont de Nemours and Company

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. c/o Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K060303

Trade/Device Name: Vanguard™ PS Open Box Porous Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 3, 2006 Received: February 6, 2006

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

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Page 2 - Ms. Susan Alexander

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. 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,

Hulin Lemon w

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):

K060303

Device Name: Vanguard™ PS Open Box Porous Femoral Components

Indications For Use:

The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:

- 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.

The device is a single use implant.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use NO (Part 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)

Helent Semenho

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

**510(k) Number** K060303

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