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The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Pectus Blu Support Bar and Stabilizers (including Pectus Blu TruLink™ Stabilizers) are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric patients (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.

The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Biomet Microfixation Twist Drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.

The Biomet Microfixation SternaLock® System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.

The Biomet Microfixation SternaLock® System is composed of metallic locking bone plates and locking screws that provide stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

The Biomet Microfixation RibFix Blu Thoracic Fixation System is in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.

The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

The Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. The device should be removed when remodeling is evident. These devices are offered as flat (unbent) bars requiring intraoperative shaping, or alternatively may be prebent to patient anatomy. These devices are intended to be used in professional healthcare facilities. The Pectus Support Bar are made of titanium alloy (ASTM F1472) or stainless steel (ASTM F138). The Pectus Stabilizers are made of stainless steel (ASTM F138) or titanium alloy (ASTM F136). The Pectus Support Bar system is provided non-sterilization by the end user.

Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

The Biomet Microfixation OmniMax MMF System is indication of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The OmniMax MMF system includes a fixation plate (also known as an arch bar) that has an in-plane bend to provide an initial approximation of mandibular and maxillary anatomy. The plate also features slots for locking screw fixation. These slots allow for a maximum of 12 fixation points in the bone as well as screw placement variation within the slot to avoid tooth roots. The OmniMax locking screws are 2.0mm in diameter and vary in length from 7mm to 11mm. The screw head also features a low-profile design to minimize irritation and palpability.

The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.

The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.