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The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia. The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.

The United Orthopedic Knee Patient Specific Instrumentation is comprised of: United Orthopedics (UO) surgical guides (hardware), anatomical models (physical replica), Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine (software), and Intelligent Surgery Knee Implant Recognition Engine (software). Enhatch is responsible for design and development of all three components of the system. The subject device is intended to facilitate the implantation of the U2 Knee protheses under the U2 Knee System developed and distributed by United Orthopedics Corporation: U2 Total Knee System. [THE SOFTWARE] The Intelligent Surgery Knee Segmentation Engine consists of two imaging modalities, CT (Knee CT Segmentation) and X-ray (Knee X-ray Segmentation). The Intelligent Surgery Knee CT Segmentation Engine and X-ray Segmentation Engine are web applications that use deep learning algorithms to detect and extract region of interest (ROI) information (femur and tibia) from medical imaging data (DICOM). The segmentation engines generate 3D models which can be used for treatment planning of Total Knee Arthroplasty (TKA), design of surgical guides, or generation of 3D printed anatomical models. The Intelligent Surgery Knee Implant Recognition Engine is a web application that uses an optimization algorithm as a treatment planning tool for total knee arthroplasty. It assists in selecting implant size and position, from a range of implants of a total knee implant system, using a range of run parameters based upon the TKA surgical technique of that system. The software identifies anatomical landmarks of the patient's bony anatomy and articular surface topographies to reference the position and alignment of the femoral and tibial implant components. This positioning and alignment in turn allows for design of surgical guides and of the United Orthopedic Knee Patient Specific Instrumentation . Note, these algorithms are static and non-adaptive; they do not alter their behavior over time based on user input. [THE HARDWARE] The UO surgical guides and anatomical models are patient-specific instruments designed to facilitate the implantation of the United Orthopedics Knee protheses. The UO surgical guides are designed based on preoperative plan generated by the software Intelligent Surgery Knee Implant Recognition Engine.

The Triathlon AS-1 patient specific cutting guides are disposable, single-use surgical instruments intended to assist orthopedic surgeons in the positioning of femoral and tibial total knee arthroplasty components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. They are intended for use with the Cruciate Retaining (CR), Condylar Stabilizing (CS), Posterior Stabilized (PS) and Tritanium® components of the Triathlon® Total Knee System and the Total Stabilizer (TS) and Posterior Stabilized Rotation (PSR) Triathlon® tibial inserts.

The subject device, Triathlon AS-1, is a new Conformis Inc. device offering. The Triathlon AS-1 is comprised of patient matched single-use disposable cutting guides (also referred to as instruments or jigs) with corresponding surgical documentation which includes the Instructions for Use, Surgical Protocol and Surgical Plan. The single-use patient-matched instruments (including documentation) are similar to those of the legally marketed predicate device Knee Replacement Systems by Conformis Inc. (predicate devices K180906, K201023). The subject device, Triathlon AS-1, does not include an implant or reusable instrumentation associated with knee replacement systems. The subject device, however, is designed to be compatible with selected legally marketed Triathlon Total Knee implants and reusable instrumentation from Stryker Orthopaedics. While no implant is part of this subject device, the subject device utilizes software to determine the size and position of the compatible implant for an individual patient and then design the subject device around the patient's anatomy to prepare for the identified implant. For the subject device, the predicate Conformis design software, surgical plan, and single-use cutting guides (instrumentation) are being modified to accurately size, position, and prepare the bone for off-the-shelf Triathlon femoral and tibial implants. Using patient imaging (CT scans), a Triathlon Total Knee implant set is sized and positioned to best meet the unique anatomic requirements of the specific patient. The Triathlon AS-1 planning process allows for efficient 3D planning, providing optimized fit of an off-the-shelf Triathlon implant and providing the design of the patient-matched, single-use guides to prepare for the planned implant in the planned position. Jigs are designed to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The design of the instrumentation will be modified as needed to be compatible with the Stryker Orthopaedics Triathlon manual surgical instrumentation. Each set of instruments is designed for single use, specifically for one patient. The disposable single-use instrument set is manufactured from biocompatible nylon material and supplied sterile.