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P.C.A. Total Hip Femoral Component Modification

by Howmedica Corp.

510(k) K852964

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)SESE Substantially Equivalent · Traditional NumberK852964 Date29 Jul 1985ClearedStatusActive

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  • Withdrawn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
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 P.C.A. Total Hip Femoral Component Modification is a medical device classified as a Blood Pressure Cuff with product code DXQ. It is a Class II device under Special Controls, designed for use in total hip replacement procedures. The modification is intended to be used as a femoral component in hip arthroplasty.

This device is supplied by Howmedica Corp. and received FDA 510(k) clearance on July 29, 1985, with the K number K852964. The device is classified as substantially equivalent. No information regarding sterility, single-use or reusable status, MRI safety, or specific sizes is provided in the data.

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Questions

AI-generated answers, 26 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 P.C.A. Total Hip Femoral Component Modification used for?

    The P.C.A. Total Hip Femoral Component Modification is designed for use as a femoral component in total hip replacement procedures, specifically for hip arthroplasty surgeries.

  • What is the regulatory status of this device?

    The device received FDA 510(k) clearance on July 29, 1985, with K number K852964, and is classified as substantially equivalent under product code DXQ with Special Controls.

  • Is the P.C.A. Total Hip Femoral Component Modification sterile or single-use?

    The device data does not provide information regarding sterility status or whether it is designed for single-use or reuse.

  • What sizes and models of this device are available?

    No information regarding specific sizes or models of the P.C.A. Total Hip Femoral Component Modification is provided in the available device data.