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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from: - trauma and vascular pathologies, either associated or non-associated to cranial decompression; - removal of tumours; - reabsorption of autologous bone; - rejection of other prosthetic materials; - congenital malformations.

CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics: - macro-pores, - interconnecting pores, - micro-pores. This material is biocompatible. The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.

The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.

The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.

The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.

The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect. The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.

Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

The Longeviti ClearFit™ OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The Longeviti ClearFit Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defect of the cranium.

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The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.

The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.