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Regenerex Patella Components

by Biomet Manufacturing Corp

510(k) K083782

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK083782 Date3 Apr 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2146-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-2068-2017 FDA Class II initiated 22 Mar 2017

    pegs shearing post-operatively

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  • Withdrawn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, 1 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 Regenerex Patella Components are orthopedic implants designed as part of a modular knee replacement system. These components are intended for use in total knee arthroplasty, providing a porous titanium patellar button to facilitate bone ingrowth and integration. The design supports cementless fixation, enhancing long-term stability and reducing the need for cement application during surgery. They are categorized under orthopedic implants and fall under the product code MBH.

These components are supplied sterile and intended for single-use in surgical settings. They are manufactured from porous titanium, ensuring biocompatibility and osseointegration with the patient’s bone. The device is regulated under FDA 510(k) clearance (K083782) and is classified as a Class II medical device. Storage and handling must adhere to sterile surgical protocols to maintain integrity before use.

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Questions

AI-generated answers, 1 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 Regenerex Patella Components used for?

    The Regenerex Patella Components are designed as part of a modular knee replacement system for total knee arthroplasty. They provide a porous titanium patellar button that encourages bone ingrowth, enabling cementless fixation. This design reduces the need for surgical cement and supports long-term stability of the knee implant.

  • Are the Regenerex Patella Components sterile and single-use?

    Yes, the Regenerex Patella Components are supplied sterile and intended for single-use in surgical settings. Sterility ensures safety for patients, and single-use reduces the risk of cross-contamination and maintains device integrity.

  • What material is used in the Regenerex Patella Components?

    The components are manufactured from porous titanium, a material chosen for its biocompatibility and ability to integrate with bone through osseointegration. This promotes stable fixation without the need for cement.

  • How should the Regenerex Patella Components be stored?

    Storage must follow strict sterile surgical protocols to preserve the device’s integrity before use. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

  • What regulatory clearance does the Regenerex Patella Components hold?

    The Regenerex Patella Components have received FDA 510(k) clearance under the reference number K083782. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.