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.

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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove knee replacement system. It details the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data.

Here's why and what information is missing:

Non-Clinical Testing: The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing (e.g., mechanical strength, wear resistance) rather than clinical performance measured against acceptance criteria. The specific acceptance criteria for these non-clinical tests and the detailed results are not provided in this summary.
Clinical Testing: Crucially, the document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." This means no human studies were conducted or provided to the FDA to demonstrate the device's clinical performance.

Therefore, I cannot provide the requested table or detailed information on studies that prove the device meets acceptance criteria because such information is not present in the provided text.

Based on the available text, here's what can be inferred or stated about the lack of the requested information:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document mentions non-clinical testing for "functional within its intended use," but no specific performance metrics or acceptance criteria are detailed.
Sample Size used for the test set and the data provenance: This information is not provided as no clinical test set was used for substantial equivalence. For non-clinical tests, details of the sample size are not given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as no clinical test set was used.
Adjudication method for the test set: This information is not applicable as no clinical test set was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. The document states "Clinical Testing: None provided as a basis for substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This question is not applicable as the device is a medical implant (knee prosthesis), not an algorithm or AI.
The type of ground truth used: This information is not applicable as no clinical studies are mentioned. For non-clinical (bench) testing, "ground truth" would typically refer to engineering standards or material properties, but these details are not provided.
The sample size for the training set: This information is not applicable as no clinical studies or AI/algorithm development (which would require a training set) are described.
How the ground truth for the training set was established: This information is not applicable for the same reasons as above.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices primarily through technological characteristics (material, design, sizing, indications) and non-clinical bench testing. It explicitly states that no clinical testing was provided as a basis for this equivalence.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Biomet Orthopedics Inc. The logo is a stylized version of the word "BIOMET" in bold, block letters. Above the logo, there is handwritten text that reads "K061433 (pg 1 of 2)".

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:

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 biomet@biome1.com

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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.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

5 - 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol with three abstract human figures connected by flowing lines, representing health and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" encircles the symbol, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

Page 1 of 1

510(k) Number K061433

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Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
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.(b)
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.