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The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metallic archbars with sliding locking plates that attach to the dental arches with self-drilling locking screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67:2013), are available in either a 7-hole or 9-hole sliding plate configuration with two different lengths, and are 0.5 mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8 mm self-drilling locking screws manufactured from Ti-6Al-4V (ASTM F136:2013). Implants are available both sterile and non-sterile. The system also includes the necessary instruments to facilitate placement of the implants.

KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of mandibular bone. 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 and production 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 engineers 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 non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

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

The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are pre-contoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm, and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self-tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). The system includes the necessary instrumentation to facilitate implantation. The purpose of this submission is to offer the previously cleared non-sterile device system in K141489 in sterile packaging via gamma irradiation.

KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, and nonunions of small bones in the hand, wrist, foot, and ankle.

The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the screws is designed to allow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self-drilling and self-tapping to eliminate the need for drilling a pilot hole prior to implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013). This system also includes the necessary and appropriate instrumentation to facilitate implantation of the screws by qualified and trained physicians.

Internal Distraction - Sterile 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, symphysis) and mid-face bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of the mandible and mid-face bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.