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The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form. Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing. The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.

The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.

The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.

The Porex Fixation System is a plate and screw system to be used in maxillofacial surgery and is provided in various configurations. The components that comprise the systems are composed of unalloyed titanium plates, titanium alloy bone screws and surgical stainless steel instruments for the installation of the screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 standard. The screws are manufactured of 6-4 ELI titanium that meets the A.S.T.M F136 standard. The screws are provided in 1.5mm diameter and 4mm length. The rescue screws are green color annodized and provided in 1.8mm diameter and 4mm length. The Porex Fixation Systems are sterilized by ethylene oxide sterilization.

The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.

The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.

The MEDPOR ATTRACTOR Implant is intended for patients who require replacement of volume of an enucleated or eviscerated orbit and who wish to gain improved prosthetic eye motility by coupling the MEDPOR ATTRACTOR Implant to the prosthetic eye.

MEDPOR Orbital Implant made of porous polyethylene with a titanium nitride coated stainless steel screw or insert. The screw or insert acts as an attractor to a magnet that is embedded into the posterior of a prosthetic eye. The magnets are gold plated and designed small enough to remain entirely within the prosthesis material of the prosthetic eye, and powerful enough to provide a coupling force between the implant and the prosthesis.

The Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.

The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the occular implant to the prosthetic eye.

Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed to be placed into the MEDPOR implant, so that the head of the screw is placed at the anterior appx of the implant as it site in the orbit. The flat head of the screw is flush with the surface of the implant and is covered with the verlying tissue. Magnets of appropriate material, shape, and size to be imbedded into the posterior of the prosthetic eye. The magnets are designed small enough to remain enlinely within the posterior of the prostinents and and any and a belgives onlike the sgrowing force between the imaterial (typically accylic) of the prosthelic eye, and powerful enough to provide a coupling force between th

MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.

MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

The devices of this submission are orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.