Search Results

SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.

SyntheCel® Dura Onlay is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. Specific Indications for Use: - Primary mandibular reconstruction with bone graft - Temporary bridging until delayed secondary reconstruction - Secondary mandibular reconstruction - Comminuted mandibular fractures - Fractures of edentulous and/or atrophic mandibles - Unstable mandibular fractures - Maxillary reconstruction with or without bone graft - Maxillary trauma

Synthes Patient Specific Plates are a metallic bone plates used in conjunction with metallic bone screws for the internal fixation of maxillofacial bone, specifically in the areas of the mandible and maxilla. The design and dimensions (number and placement of holes, hole angulation, plate length, etc.) of each plate are based on of the patient's anatomic (CT scan) data, the surgical plan, and input from the surgeon. Synthes Patient Specific Plates are not intended to be further bent or contoured during surgery. Synthes Patient Specific Plates are manufactured from commercially pure titanium, are provided non-sterile, must be sterilized prior to use, and are intended for single use only.

The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery: - . Trauma - . Reconstructive surgery - . Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use). MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The Synthes Curvilinear Distraction System is intended for single use only.

The Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvilinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. Synthes Curvilinear Distraction System devices are manufactured from titanium alloy and chromium cobalt alloy. Devices are supplied non-sterile and must be sterilized prior to use. The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components: Track, Worm gear activation assembly, and Housing.

The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery: - Trauma - Reconstructive surgery - Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System. These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. Specific indications (SynPOR HD Ocular Spheres): • Ocular reconstruction • Socket preservation Specific indications (SynPOR HD Facial Shapes): • Enhancement of the malar and chin • Correction of deficiencies of the malar and chin

SynPOR HD Porous Polyethylene Three Dimensional Implants are devices intended for ocular reconstruction and socket preservation, enhancement of the midface and mandibular skeleton, and correction of deficiencies of the midface and mandible. The porous structure of the HDPE material allows for fibrovascular ingrowth. The implants include facial shapes (chin and malar implants for aesthetic and reconstructive surgery to augment the contours of the craniofacial skeleton) and ocular spheres (for restoring the volume of an eviscerated or enucleated eye globe). SynPOR HD Porous Polyethylene Implants are delivered sterile for single patient use and should not be resterilized.

The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.