Vanguard Patella Components

• • Terminated Z-2154-2020 FDA Class II ·initiated 17 Apr 2020

  Potential presence of elevated endotoxin levels that exceed the specification limit

• • Terminated Z-0937-2019 FDA Class II ·initiated 21 Dec 2018

  Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

• • Terminated Z-1861-2017 FDA Class II ·initiated 17 Feb 2017

  Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

• 10 recalls, same reason

  • Terminated Z-0700-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0698-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0704-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0701-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0699-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0696-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0702-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0703-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0695-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011
  • Terminated Z-0697-2012 FDA Unclassified (pre-2012) ·initiated 4 Oct 2011

  Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

510(k) Number

K040770 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →

• What is the Vanguard Patella Component used for?

  The Vanguard Patella Component is an orthopedic implant designed for knee joint replacement, specifically indicated for cemented use in knee arthroplasty procedures to replace the patellar surface.

• What fixation options are available for the Vanguard Patella Component?

  The Vanguard Patella Component is available with single or 3-peg fixation options, allowing surgeons to choose based on patient anatomy and surgical preference for cemented implantation.

• Does the Vanguard Patella Component include an x-ray wire option?

  Yes, the Vanguard Patella Component is available with or without an x-ray wire, providing flexibility for intraoperative visualization and postoperative imaging needs.

• Who manufactures the Vanguard Patella Component and what is its regulatory status?

  The Vanguard Patella Component is manufactured by Biomet Manufacturing, Inc. and has received FDA 510(k) clearance under submission number K040770, confirming its substantial equivalence to a legally marketed device.