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OrthoLoc Advantim Tibial Base Component

by Dow Corning Wright 510(k)

Active United States

510(k) K932858

Overview

The OrthoLoc Advantim Tibial Base Component is a tibial base component for knee prostheses, designed to provide structural support and stability in total knee arthroplasty procedures. It is classified as an orthopedic implant intended to replace damaged or diseased tibial surfaces, facilitating improved joint function and mobility for patients.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is manufactured under FDA 510(k) clearance (K932858) as a substantially equivalent orthopedic implant, adhering to traditional review pathways. The component is part of a modular knee system and requires proper surgical technique for implantation, with no specific MRI safety restrictions noted in the regulatory data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932858 Date16 Feb 1994ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the OrthoLoc Advantim Tibial Base Component used for?

    The OrthoLoc Advantim Tibial Base Component is designed as a tibial base component for knee prostheses. It is intended to replace damaged or diseased tibial surfaces during total knee arthroplasty procedures, providing structural support and stability to restore joint function and improve patient mobility.

  • Is the OrthoLoc Advantim Tibial Base Component sterile and single-use?

    Yes, the OrthoLoc Advantim Tibial Base Component is supplied sterile and intended for single-use in orthopedic surgical settings. This ensures patient safety and reduces the risk of infection or cross-contamination.

  • What regulatory clearance does this device have?

    The OrthoLoc Advantim Tibial Base Component holds FDA 510(k) clearance under the reference number K932858. It was determined to be substantially equivalent to a legally marketed device through the traditional review pathway, adhering to FDA orthopedic implant standards.

  • Is this component part of a modular knee system?

    Yes, the OrthoLoc Advantim Tibial Base Component is designed as part of a modular knee system. This modularity allows surgeons to customize the knee prosthesis to better fit individual patient anatomy and clinical needs during surgery.

  • Are there any specific MRI safety restrictions for this device?

    Based on the available regulatory data, there are no specific MRI safety restrictions noted for the OrthoLoc Advantim Tibial Base Component. However, surgeons should always follow standard protocols and consult manufacturer guidelines for MRI compatibility in implanted devices.