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Vanguard Removable Molded Poly Tibia

by Biomet Manufacturing Corp 2 variants

510(k) K060525

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK060525 Date25 May 2006ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2151-2020 FDA Class II initiated 17 Apr 2020
    • Terminated Z-2152-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • 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.

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 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 Removable Molded Poly Tibia is a knee prosthesis component designed to replace the tibial articulating surface in total knee arthroplasty. It is classified as a prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer device under product code JWH. The system consists of three parts: a cobalt-chromium-molybdenum (Co-Cr-Mo) tibial plate, an ultra-high-molecular-weight polyethylene (UHMWPE) tibial bearing, and a titanium-6-aluminum-4-vanadium (Ti-6AL-4V) insert.

This device is implanted by orthopedic surgeons in a clinical or operating room (OR) setting during total knee arthroplasty procedures. It is supplied as a sterile, single-use implant and is intended for use in cemented knee replacement surgeries. The device received FDA 510(k) clearance (K060525) and is regulated as a Class II medical device with special controls. No MRI safety information is provided in the data.

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Questions

AI-generated answers, 21 Sep 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 Removable Molded Poly Tibia used for?

    It is used to replace the tibial articulating surface in total knee arthroplasty procedures, specifically designed for cemented knee replacement surgeries where it is implanted by orthopedic surgeons in a clinical or operating room setting.

  • How is the Vanguard Removable Molded Poly Tibia supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only during surgery and must not be reprocessed or reused due to risks of contamination, material degradation, and compromised performance.

  • What materials make up the Vanguard Removable Molded Poly Tibia system?

    The system consists of three components: a cobalt-chromium-molybdenum (Co-Cr-Mo) tibial plate, an ultra-high-molecular-weight polyethylene (UHMWPE) tibial bearing, and a titanium-6-aluminum-4-vanadium (Ti-6AL-4V) insert, which together form the tibial articulation in a cemented knee prosthesis.