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Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

by Implex Corp.

510(k) K980486

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 NumberK980486 Date14 Apr 1998ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1954-2016 FDA Class II initiated 15 Apr 2016
    • Terminated Z-1955-2016 FDA Class II initiated 15 Apr 2016 on shared 510(k) K980486

    Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Implex Hep Acetabular Revision Cup is a prosthetic component designed for hip arthroplasty. It is indicated for use in cases of severe joint degeneration or trauma and functions as an acetabular component for total hip replacement.

This system is available in outer diameter sizes ranging from 40 mm to 72 mm and inner diameter sizes of 22, 26, 28, and 32 mm. The device is implanted using the Implex Acetabular Cup Instrumentation System and has received FDA 510k clearance.

Other devices from Implex Corp.

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Questions

AI-generated answers, 22 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 intended use of the Implex Hep Acetabular Revision Cup?

    This prosthetic component is designed for use in total hip arthroplasty procedures. It is specifically indicated for patients requiring a revision cup due to severe joint degeneration or trauma.

  • What size options are available for this revision cup system?

    The system offers a range of sizing to accommodate different patient anatomies. The outer diameters range from 40 mm to 72 mm, while the inner diameters are available in 22 mm, 26 mm, 28 mm, and 32 mm.

  • How is the Implex Hep Acetabular Revision Cup implanted?

    The device is designed to be implanted using the Implex Acetabular Cup Instrumentation System. It is compatible with both cemented and cementless surgical techniques as part of the A-240 system.

  • What is the regulatory status of this device?

    The Implex Hep Acetabular Revision Cup, Model A-240 System, has received FDA 510k clearance under submission number K980486, having been determined to be substantially equivalent to existing devices.