VANGUARD REMOVABLE MOLDED POLY TIBIA

K060525 · Biomet Manufacturing Corp · JWH · May 25, 2006 · Orthopedic

Device Facts

• Record ID: K060525
• Device Name: VANGUARD REMOVABLE MOLDED POLY TIBIA
• Applicant: Biomet Manufacturing Corp
• Product Code: JWH · Orthopedic
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• 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 or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for use with bone cement.

Device Story

Vanguard™ Removable Molded Polyethylene Tibia is a knee prosthesis component replacing the tibial articulating surface. System consists of three parts: tibial tray, tibial bearing, and insert. Device is implanted by orthopedic surgeons in a clinical/surgical setting. It functions as a semi-constrained, cemented implant to restore joint function and alleviate pain in patients with degenerative or traumatic knee conditions. The I-beam profile of the tibial tray and the articulating surface design are derived from previously cleared Biomet systems. The device is intended for single use with bone cement.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Semi-constrained, cemented knee prosthesis. Materials: UHMWPE (direct molded) and metal. Components: Tibial tray, tibial bearing, and insert. Design features an I-beam profile tibial tray. Intended for use with bone cement.

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 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® Removable Molded Polyethylene Tibia (Pop-Top) (K991753 and K984623)
• Vanguard™ System (K023546)

Submission Summary (Full Text)

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Ka60525

## 510(k) Summary

Preparation Date: 24 February 2006

MAY 2 5 2006

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Tracy Bickel Johnson, RAC

Proprietary Name: Vanquard™ Removable Molded Polyethylene Tibia (Pop-Top)

Common Name: knee prostheses

Classification Name: JWH- prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (888.3560)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Removable Molded Polyethylene Tibia (Pop-Top) - K991753 and K984623 (Biomet, Inc.): Vanquard™ System- K023546 (Biomet, Inc.)

Device Description: Vanguard™ Removable Molded Polyethylene Tibia is intended to replace the tibial articulating surface in a joint replacement along with femoral components that were cleared in K023546. There are three parts to the Vanguard™ Removable Molded Polyethylene Tibia component: the tibial tray, tibial bearing, and an insert.

The I-beam profile of the tibial tray is identical to that of the Maxim® tibial tray cleared in the following submissions K984623 and K991753. The articulating surface is identical to the surface cleared in K023546.

### Intended Use:

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

The device is a single use implant intended for use with bone cement.

Summary of Technologies: The technological characteristics (direct molding UHMWPE onto the tibial tray and the Vanguard™ articulating surface) of the Vanguard™ Removable Molded Polyethylene Tibia are similar to or identical to the predicate devices.

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

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

All trademarks are property of Biomet, Inc.

MAILING ADDRESS 1:0. Box 587 Warsaw, IN 46581 0587 - - - -

SHIPPING ADDRESS 56 E. Bell Drive Warsow, IN 46582

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()Ff-1Ct; 574. 267.6659

I'AX 574.267 81.47

E-MAH. [e-mail]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 5 2006

Biomet Manufacturing Corp c/o Mr. Tracy Bickel Johnson 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581

Re: K060525

Trade/Device Name: Vanguard Removable Molded Polyethylene Tibia Regulation Number: CFR 888.3560 . Regulation Name: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Regulatory Class: Class II Product Code: JWH Dated: February 24, 2006

Received: February 27, 2006

Dear Mr. Johnson:

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 -- Mr. Tracy Bickel Johnson

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.

Hebert Lerner mo

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: Vanguard™ Removable Molded Poly Tibia

Indications For Use:

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

The device is a single use implant intended for use with bone cement.

Prescription Use × (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)

Herbert Simmering

sion Sign-Off Division of General. Restorative. and Neurological Devices

**510(k) Number** K060525

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