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Vanguard Anatomic Patella Groove (APG) / Vanguard V Groove

by Biomet Manufacturing, Inc.

510(k) K061433

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061433 Date21 Aug 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBH
Device Class
Class II
Regulation
21 CFR Part 888.3565
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vanguard Anatomic Patella Groove (APG) / Vanguard V Groove is a two-piece knee joint replacement system that replaces the patellofemorotibial joint space. It includes cruciate-retaining femoral components and all-polyethylene patellae. The system is designed to replace the natural joint space with artificial components. The device is used in orthopedic applications.

The Vanguard Anatomic Patella Groove (APG) / Vanguard V Groove is supplied with various components, including left and right femoral components and different patella designs. The device has been cleared by the FDA with a 510K clearance. It is manufactured by Biomet Manufacturing, Inc. and has a product code of MBH.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vanguard Anatomic Patella Groove used for?

    The Vanguard Anatomic Patella Groove is used in orthopedic applications to replace the natural joint space with artificial components, specifically the patellofemorotibial joint space.

  • What components are included in the Vanguard Anatomic Patella Groove system?

    The system includes left and right femoral components and different patella designs, including all-polyethylene patellae.

  • How is the Vanguard Anatomic Patella Groove supplied?

    The device is supplied with various components, including left and right femoral components and different patella designs, to accommodate different patient needs.

  • What is the regulatory status of the Vanguard Anatomic Patella Groove?

    The device has been cleared by the FDA with a 510K clearance, indicating that it is substantially equivalent to a predicate device.