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The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.

KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin personnel during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Implants are provided sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

The KLS Martin LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, where applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.

The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws. The purpose of this premarket notification is to offer the implants sterile.

The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.

The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.

The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0 mm to 3.0 mm and screw diameter ranges from 2.3 mm to 3.2 mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stabilized fixation. The device has a three position screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.

The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.

KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The KLS Martin Xternal Fixator consists of 3.2mm titanium pins in various lengths that are fixated to the bone. The titanium pins are held in place with titanium pin clamps and a 4mm titanium rod or can be held in place with an acrylic bar and titanium screw caps.

To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating System in sterile packaging with the following indications for use: K062857 KLS Martin Quick Disc is intended for reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures. K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for stabilization and fixation of antenor chest wall fractures including sternal fixation subsequent to stemotomy and sternal reconstructive procedures.

The KLS Martin Quick Disc is a two-sided cranial closure device. The lower disc is attached to a threaded post. The upper disc is threaded down and locked on the post securely holding the bone flap in place. The KLS Martin Quick Disc diameters range from 12mm to 22mm in size The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open A second emergency re-entry is position. provided by cut points adjacent to the screw. KLS - Martin Sternal Plating System consists of plates having a thickness from 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.