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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033. The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard. The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)

The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques.

The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.

The Bioplate Resorbable Bone Tack consists of a bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer that has been implanted safely for a number of years. The bone fixation devices will be provided sterile to the end-user, using gamma radiation as the method of sterilization and are not intended for re-sterilized by the enduser.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The Bioplate® Riqid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants. The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The modified plates designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue. The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.

The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. The bone plates will be manufactured of commercially pure titanium.

The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull. The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.

The Bioplate® Battery Powered Drill is comprised of a metal housing, containing the motor, designed to withstand steam sterilization. Two forward speeds are activated using control buttons on the body of the unit. There is no reverse. The operating portion of the instrument has a quick release mechanism that is designed to hold stainless steel drill bits for drilling pilot holes into bony tissue prior to insertion of self-tapping bone screws. Four (4) AAA batteries (sterile, unitized or non-sterile) are inserted into the back portion of the handle prior to use.