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MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.

The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.

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 Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The subject Keos Anterior Cervical Interbody Fusion Device (IBFD) System is composed of anterior cervical spacers and associated instruments. Keos Anterior Cervical IBFD cages are manufactured from polyetheretherketone (PEEK) according to ASTM F2026, as well as Hydroxyapaetite (HA) Enhanced PEEK. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Keos Anterior Cervical IBFD cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. Additionally, the device contains six (6) tantalum marker balls per ASTM F560 to provide imaging visibility for device positioning. The Keos Anterior Cervical Interbody Fusion Device System implants are intended for single use only. All components of the Keos Anterior Cervical IBFD System are provided non-sterile, to be sterilized by the end user.

The Keos Lumbar IBFD is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) of the spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and rod systems.) The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF. a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.

The Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion (IBF). They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are made from PEEK radiolucent material and Hydroxyapatite (HA) Enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively. Surgical instruments are required for implantation of the device. The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11), 465 Stainless Steel, Silicon, 6061 Aluminum, 300 and 400 Series Stainless Steel.

Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists. Keosys Medical Imaging Suite is a software application intended to aid in diagnostic and evaluation of medical image data. Although this device allows the visualization of mammography images, it is not intended as a tool for primary diagnosis in mammography. Keosys Medical Imaging Suite can be used for display, process, temporarily store, print and also create and print reports from 2D and 3D multimodal DICOM medical image data. The imaging data can be Computed Tomography (CT), Magnetic Resonance (MR), Radiography X (CR, DX, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT, Gated SPECT), Positon Emission Tomography (PT), Ultrasound (US). Keosys Medical Imaging suite provides tools like rulers, markers or region of interests (e.g. it can be used in an oncology clinical workflow for tumor burden assessment or therapeutic response evaluation). It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.

Keosys' Advanced Medical Imaging Software Suite (aka Viewer, aka KSWVWR) is a multimodality diagnostic workstation for visualization and 3D post-processing of Radiological and Nuclear Medicine medical images. It includes dedicated applications for the therapeutic response evaluation process in a multi-vendor, multi-modal and multi time-points context. The solution also includes the latest recommendations for SUV calculation.

Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors. The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution. It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.

Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography. Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM. Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device. Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.