APEX HOLE ELIMINATOR PS

K963309 · Depuy, Inc. · LPH · Nov 12, 1996 · Orthopedic

Device Facts

• Record ID: K963309
• Device Name: APEX HOLE ELIMINATOR PS
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.

Device Story

Threaded plug device; designed for Duraloc series two-piece acetabular cups; used in hip arthroplasty. Function: closes apical hole in metal shell; prevents blood/particle migration from behind shell; prevents cement extrusion during cemented implantation; provides congruent support for polyethylene liner to prevent cold flow. Operation: manual insertion into acetabular shell; can be placed pre- or post-cup insertion depending on cementless or cemented technique. Benefit: maintains shell integrity; supports liner; prevents debris/cement migration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: forged Ti-6Al-4V. Design: threaded plug with trailing edge taper for locking. Application: accessory for Duraloc series acetabular cups.

Indications for Use

Indicated for patients undergoing hip arthroplasty requiring closure of the apical hole in Duraloc series two-piece acetabular cups to prevent fluid/particle migration or cement extrusion and to provide structural support for the polyethylene liner.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• DePuy Duraloc® 100C Acetabular Cup (K963309)
• Wright Medical Interseal™ Acetabular Components

Submission Summary (Full Text)

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510K SAFETY AND EFFECTIVENESS SUMMARY

K963309

NAME OF FIRM:
DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988
NOV 12 1996

510(k) CONTACT:
Cheryl Hastings
Manager, Clinical Affairs

TRADE NAME:
Apex Hole Eliminator PS

CLASSIFICATION NAME:
Prosthesis, Hip, Semi-constrained (metal uncemented) Acetabular Component
(Regulation number: 888.3330)

SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Duraloc® 100C Acetabular Cup
Wright Medical Interseal™ Acetabular Components

INTENDED USE AND DEVICE DESCRIPTION:
The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.

BASIS OF SUBSTANTIAL EQUIVALENCE:
The Apex Hole Eliminator PS is substantially equivalent to the apical hole plug which was cleared with the DePuy Duraloc 100C Acetabular Cup and to the apical hole plug used with the Wright Medical Interseal Acetabular Components in that they have similar designs and the same intended use. The differences between the Apex Hole Eliminator PS and the Duraloc 100C apical hole eliminator are: 1) the Apex Hole Eliminator PS is manufactured from forged Ti-6Al-4V while the Duraloc 100C apical hole eliminator is manufactured from forged Co-Cr-Mo; and 2) the Apex Hole Eliminator PS has standard threads and a taper on the trailing edge to lock it into the acetabular shell. The Duraloc 100C apical hole eliminator has interference locking threads to fasten it to the acetabular shell.

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