Implex A-240 Hep Acetabular Cup System

• • Terminated Z-1955-2016 FDA Class II ·initiated 15 Apr 2016

  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.

510(k) Number

K964509 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• The Trabecular Metal Technology Acetabular Augment System, Models 4893-Xx-Yy (Zimmer), 02-212-05XX1 ( Implex)

  Class II

  FDA 510(k) K012507 Active Cleared 30 Aug 2001

• Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1

  Class II

  FDA 510(k) K051196 Active Cleared 17 Jun 2005

• Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

  Class II

  FDA 510(k) K022563 Active Cleared 30 Aug 2002

• Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution

  Class II

  FDA 510(k) K031449 Active Cleared 23 Sep 2003

• Implex Continuum Porous Patellar

  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

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

  Class II

  FDA 510(k) K980486 Active Cleared 14 Apr 1998

See all devices from Implex Corp. →

• What clinical situations is the Implex A-240 Hep Acetabular Cup intended for?

  It is designed for total hip replacement in patients with severe joint degeneration or trauma, providing a durable, porous tantalum shell that encourages bone ingrowth without cement.

• How is the cup supplied and what are the size options?

  The system is supplied as a single‑use device and comes in outer diameters ranging from 40 mm to 72 mm, with corresponding inner diameters of 22, 26, 28, and 32 mm, allowing surgeons to match patient anatomy.

• What instrumentation is required for implantation?

  Implantation uses the Implex Acetabular Cup Instrumentation System, which is specifically engineered to position the porous tantalum shell accurately during surgery.

• What storage conditions are recommended for the cup?

  The device must be stored according to the manufacturer’s specifications, typically in a controlled environment that protects the porous tantalum shell from contamination and maintains its sterility until use.

• What regulatory clearance does the Implex A-240 Hep Acetabular Cup have?

  The cup received FDA 510(k) clearance (K964509) on June 19 1997, classified under product code LPH, indicating it is substantially equivalent to a legally marketed predicate device.