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Modular Cathcart Fracture System

by Depuy, Inc. 510(k)

Active United States Open recall

510(k) K903084

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903084 Date3 Oct 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1375-2022 FDA Class II initiated 18 May 2022

    The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.

Specification

510(k)

510(k) Number
FDA Product Code
LZY
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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 Modular Cathcart Fracture System is a metal femoral hemi-hip prosthesis. It is designed to function as a replacement component for the hip joint.

This device is regulated under FDA 510(k) number K903084. It is classified as a class 2 medical device.

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