VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE

K061433 · Biomet Manufacturing, Inc. · MBH · Aug 21, 2006 · Orthopedic

Device Facts

• Record ID: K061433
• Device Name: VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
• Applicant: Biomet Manufacturing, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• 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. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Device Story

Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove is a two-piece knee joint replacement system; replaces patellofemorotibial joint space. System includes cruciate-retaining femoral components (left/right configurations; Interlok® or porous finish) and all-polyethylene patellae (round modified dome or medially offset designs). Patellae feature 3-pegs, concentric grooves, and cement pockets. Used with Biomet® Tibial Trays, Vanguard™ CR, CR-L, or AS bearings/augments. Intended for surgical implantation by orthopedic surgeons to restore joint function and alleviate pain in patients with degenerative or traumatic knee conditions.

Clinical Evidence

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

Technological Characteristics

System consists of metal femoral components (Interlok® or porous-coated) and all-polyethylene patellar components. Design features include 3-peg patellar fixation, concentric grooves, and cement pockets. Sizing ranges from 55-80mm. Fixation methods include cemented or uncemented biological fixation depending on component coating.

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

• Vanguard™ (Maxim® Accel) (K023546, K033489)
• Vanguard™ Patella (K040770)
• UHMWPE Components (K921182)
• Avon™ PFJ Prosthesis (K041160, K020841, K051948)
• Insall/Burstein® II (K872379)
• Performance® Knee System (K874547)
• NexGen® All-Poly Patella (K972270)
• Duracon® CR (K032163)

Submission Summary (Full Text)

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AUG 2 1 2006

### 510(k) Summary

Preparation Date: May 23, 2006

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Tracy Bickel Johnson, RAC

Proprietary Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove

Common Name: femoral and patella components

#### Classification Name(s):

- Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (888.3560)
- · Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (888.3565)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard™ (Maxim® Accel) -K023546 and K033489 (Biomet, Inc.), Vanguard™ Patella- K040770 (Biomet, Inc.), UHMWPE Components- K921182 (Biomet, Inc.), Avon™ PFJ Prosthesis ~ K041160, K020841, and K051948 (Stryker/Howmedica/Osteonics), Insall/Burstein® II – K872379 (Biomet, Inc.), Performance® Knee System -K874547 (Biomet, Inc.), NexGen® All-Poly Patella – K972270 (Zimmer Holdings), Duracon® CR – K032163 (Stryker/Howmedica/Osteonics)

#### Device Description:

The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment.

The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm.

Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.

> MAILING ADDRESS 120. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582

OFFICE 574.267.6639

574.25.137

I:-MAIL [e-mail]

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K061433 (pg 2 of 2)

#### 510(k) Summary Vanguard™ (APG) / Vanguard™ V Groove Page 2 of 2

#### 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.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Vanguard™ APG 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 belong to Biomet, Inc. except the following:

Avon is a trademark of Stryker/Howmedica/Osteonics Insall Burstein II is a trademark of Zimmer Holdings NexGen is a trademark of Zimmer Holdings Duracon CR is a trademark of Stryker/Howmedica/Osteonics

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 1 2006

Biomet Manufacturing Corp. % Tracy Bickel Johnson, RAC Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K061433

Trade/Device Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove Regulation Number: 21 CFR 888.3565

Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented

prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: May 23, 2006 Received: May 24, 2006

Dear Ms. 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 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 - Ms. Tracy Bickel Johnson );

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,

Barbara Brien

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):_KO6/ 433

Device Name: Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove

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.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Prescription Use メ (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)

Lubara Buchard franken

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K061433

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