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Consensus Zirconia Femoral Head

by U.S. Medical Products, Inc.

510(k) K955386

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)SN Traditional NumberK955386 Date20 Feb 1996DecidedStatusActive

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 23 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 Consensus Zirconia Femoral Head is a femoral head component used in hip arthroplasty systems. It is designed to articulate with a corresponding acetabular cup to restore joint function in total hip replacement procedures.

This device is supplied as a reusable implant component intended for use in orthopedic surgical settings. It is provided non-sterile and requires sterilization prior to use. The device is authorized under FDA 510(k) clearance K955386 with product code LZO and was determined to be substantially equivalent for some indications.

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Questions

AI-generated answers, 23 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 Consensus Zirconia Femoral Head used for?

    The Consensus Zirconia Femoral Head is a femoral head component used in hip arthroplasty systems to articulate with a corresponding acetabular cup, restoring joint function in total hip replacement procedures.

  • Is the Consensus Zirconia Femoral Head sterile when supplied?

    The device is provided non-sterile and requires sterilization prior to use, as it is intended for reuse in orthopedic surgical settings after proper reprocessing.

  • How is the Consensus Zirconia Femoral Head supplied and intended for use?

    It is supplied as a reusable implant component for orthopedic surgical settings, meaning it is designed to be cleaned, sterilized, and reused multiple times following validated reprocessing protocols.

  • What regulatory pathway was used for the Consensus Zirconia Femoral Head?

    The device was authorized under FDA 510(k) clearance K955386 with product code LZO and was determined to be substantially equivalent for some indications based on its traditional submission.