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The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.

The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics: • The implants are designed individually for each patient to correct defects in cranial bone. - The implants are 3D printed using material extrusion technology. - The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF). - The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input. - · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm. - If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs. - The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems - The implants are provided non-sterile for sterilization prior to implantation.

MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized. MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing. Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient. The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.

The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold). The Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in the reconstructive process. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to achieve fixation. If necessary, the plate may be bent or cut to meet the anatomical needs of the patient. The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.

The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).

Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is an individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone), ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long. A Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a specific patient's skull whereas a Customized Craniofacial Implants (CCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, which are both considered load bearing areas of the facial region of the skull. The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific Base Implant that are used to support the base implant in the bony void or defect area while providing for a "Precise Fit". The single patient use base implant is (1) fabricated from a billet block of natural implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer using the patient's CT Scan imaging data, (2) provided clean but non-sterile for steam sterilization prior to implantation at a hospital or surgical site with neurosurgery capabilities, and (3) attached to the native bone using commercially available cranioplasty hardware and fasteners. The additional features listed below are additional design elements that may be added to the Base Implant and Base Implant with Perfusion Holes, as requested by the Physician. The Base Implant, as defined above (as previously cleared on K103582 and K121755).

Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing. The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use. Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient

The Universal Mesh is indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher). The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.

The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh. The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.