Search Results

The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients. The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants).

The Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart) is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide. Through this submission there is no change to the existing articles within the Delta System. The scope of this submission covers the addition of screws to the Delta System, which are shown as a modification of screws of the reference device to create the addition of self-tapping screws (STS) and low profile emergency screws (LPES). The subject STS and LPES, only, have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

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 NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.

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 Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.

The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are: 1. UN III AXS Screws packed in sterile procedure packs, and 2. UN III AXS Screws packed in a sterile screw cartridge.

The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 or higher). The UN III System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. This special 510(k) is being submitted due to dimensional modifications to the screw and screwdriver blade. There have been no modifications to the plates, meshes, or other accessory devices.

The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, and sheets. In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

DePuy Synthes RAPIDSORB IPS Injectable Polymer System consists of a sterile resorbable polymer, 85:15 Poly (L-lactide co-glycolide) and a battery powered delivery device. The polymer can be extruded from the delivery device into a predrilled pilot hole at the surgical site. The polymer is presented as a rod in a sterile package (cartridge) that fits into the delivery device. The device then briefly heats the polymer at the implant site beyond the glass transition temperature of the polymer, allowing the polymer to be extruded in a controlled manner in a preselected length from the device through a plate, mesh, or sheet and into a predrilled hole at the site of the defect. The extruded polymer fills the predrilled hole. Retention is attained through friction and interdigitation with the surrounding bone. The delivery device consists of three principal components: 1) a Power Drive Unit, which is nonsterile and reusable, and which fits into and is enclosed by 2) a disposable, sterile, single-use, rigid plastic shell and cap, and 3) a sterile, single-use, battery pack that attaches to the shell and serves as the power source. The delivery device is comfortably shaped and balanced to fit the left or right hand of the surgeon. Enclosing the Power Drive Unit thus assures sterile delivery of the polymer at the implant site. The brevity of the increase in the temperature of the polymer combined with the controlled, minimized volume of polymer implanted prevents tissue injury or necrosis at the implant site.

Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, 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 3 colors (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, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag. 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 Innovasis Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

The Innovasis« Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The single use devices are a variety of low profile plates and anchoring screws that fixate bone pieces together in the cranial area of the patient. The design features include: - · Commercially Pure Titanium or 6 Al 4V Titanium Alloy - · Straight and Square plates - · Double Y plates - Burr hole plates - · Plates with Shunts - · Self-Drilling/Self-Tapping Screws - Mesh - · Instrumentation to customize size, shape and placement of implants - · Compact sterilization tray to optimize organization of implants