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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).

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.

The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.