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The KMTI Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

The Kyocera Medical Technologies, Inc. (KMTI) Initia T3 Acetabular Hemispherical Shell System is a cementless shell intended for use in the treatment of hip disorders requiring hip replacement surgery. The Initia T3 Acetabular Hemispherical Shell System includes several components including: Initia T3 Acetabular Hemispherical Shell, Initia Acetabular Liner, Initia Bone Screw, and Delta 22.2 Femoral Head. The Initia T3 Acetabular Hemispherical Shell is a cementless porous shell manufactured from Ti-6Al-4V ELI per ASTM F136. The Initia Acetabular Liner attaches to the inner surface of the Initia T3 Acetabular Hemispherical Shell and is available in four different configurations. The Initia Acetabular Liner is used to provide a single articulation implant option and is manufactured from Vitamin E infused UHMWPE per ASTM F2695 or UHMWPE per ASTM F648. The femoral head is manufactured from Biolox® delta and is available in two offsets.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt. When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth. The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.

The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level. The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers. The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface. Bullsai Confirm is used to do the following: - Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images. - . Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage - . Combine MR images, CT images, and patient specific 3D structures for more detail - Localize graphical compatible DBS lead models (based on preoperative imaging) . - . Visualize VTA fields relative to structures of interest in the patient anatomy or lead position The software provides a workflow for clinicians to: - Create patient-specific stimulation plans for DBS programming . - . Export reports that summarize stimulation plans for patients (PNG screenshot)

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine. The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Tesera-k Lumbar System (Tesera-k PL (Tk-PL) System and Tesera-k XL System (Tk-XL) System) consist of interbody fusion implants intended to provide stability and facilitate fusion in the lumbar spine. The Tesera-k PL System implants are offered with straight or curved profiles to accommodate posterior or transforaminal surgical approaches. The Tesera-k PL implants are additively manufactured then machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The Tesera-k XL System implants are offered in a straight profile for the direct lateral surgical approach. The Tesera-k XL cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V ELI) per ASTM F3001. The Tesera-k XL Bone Screws and Locking Assemblies are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

The Initia Knee System is intended for use in total knee arthroplasty for the following indications: 1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for cemented use only.

The Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis intended to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The Initia Knee System includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level. The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach. The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.

TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer. The device is for a single patient's use only and can be reused throughout the entirety of the treatment course. The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by on the order of a physician and is by prescription only.

TrueFit/TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the radiation therapy bolus (TrueFlex) by 3D Bolus Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus is 3D printed by MJF technology using polyamide or polyurethane material. A Final TrueFlex Bolus device is manufactured by filling a mould with silicone. The bolus is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The bolus acts as a tissue-equivalent material placed on the patient skin to account for the buildup region of the treatment beam.

The 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach. The 3D Printed PEEK Interbody System (Cervical) is intended for spinal fusion procedures in the cervical spine at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.

The 3D Printed PEEK Interbody System devices are spinal fusion implants that are inserted into the intervertebral body space of the spine to act as disc spacers and hold bone graft. These devices are manufactured from PEEK OPTIMA™ LT1AMR5 with tantalum radiographic markers and are offered in multiple footprint, height, and lordotic angle options.