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The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon. The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file. KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.

The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon. The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.

The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

The Stryker CMF MEDPOR Customized Implant, also referred to as MEDPOR CIs, product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. These MEDPOR CIs are currently packaged into MEDPOR CI Kits with a patient-specific Host Bone Model (HBM) that represents the 3D patient's anatomy surrounding the defect location. This Special 510(k) is submitted specifically to include the customer option to sell new Stryker CMF MEDPOR Priority Customized Implant Kits without the Host Bone Model subcomponent.

The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.

SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.

The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.

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

The Stryker CMF MEDPOR® Customized Implant is sold as a kit of two identical implants plus one host bone model. The Stryker CMF MEDPOR Customized Implants are molded from porous high density polyethylene (HDPE) to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request. The porous structure of the MEDPOR material allows for tissue ingrowth. The implant is fixed into place using compatible Stryker fixation systems. The implants and host bone model are provided sterile for single use only.

The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

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

The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.

PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.