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The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher). Specific Indications for Use: - Orbital reconstructive/ trauma surgery

The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use. The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.

CMRP: The Customized Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation. SMRP: The Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone araft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

The subject devices include the Stryker Customized Mandible Recon Plate (CMRP) and Stryker Surgeon iD Mandible Recon Plate (SMRP). Both CMRP and SMRP are intended to be used for rigid internal fixation of primary, secondary mandibular reconstructions, and fixation of mandibular fractures; and have an indication for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation. Subject devices have similar intended use and technical characteristics as the primary predicate device (K193136) and the reference device (K190696), and the additional language in indications for use statement is supported by the reference device (K014263). The subject devices' plate(s) are designed and manufactured for one patient and/or surgeon specifically, and the customized patient-specific and surgeon-specific design of the plate(s) allows certain features to be configured to meet the individual needs of each patient and surgeon. The subject devices' plate has additional design configuration options (such as branches and flanges, and updated plate bar widths of 5.75-7.5mm) when compared to the primary predicate device. The subject devices' plate(s) are provided with the Design Proposal document, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the subject device is compatible with a separately provided Surgical Guides accessory.

Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.

The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.

The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

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