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OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: - Pre-operative planning of total hip arthroplasty (THA) - Intraoperative navigated surgery for THA using a posterior approach

OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery. The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140). OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system. OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions. OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data. OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data. The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery. The OTS Hip is compatible with the following components: - PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100 - Emphasys offset reamer, DePuy Synthes 4811-00-510 - Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115 - Pinnacle straight impactor, DePuy Synthes 2217-50-041 - Emphasys straight impactor, DePuy Synthes 4812-00-150 - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long) - Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long) - Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short)

OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: - Pre-operative planning of Total Hip Arthroplasty (THA) - Intraoperative navigated surgery for THA using a posterior approach

OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery. OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system. OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the quidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions. OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data. OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaqinq data. The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery.

The Ortoma Treatment Solution system is intended to be an intraoperative image-guided localization system to enable navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by OTS platform, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for hip surgical procedures, in which the use of navigated surgery is considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a hip prosthesis to the preoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Total Hip Arthroplasty (THA) using posterior approach. Preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups.

The Ortoma Treatment Solution – OTS is a stereotactic navigation system, supporting the surgeon with positioning information in relation to the individual patient anatomy before and during orthopedic hip joint replacement surgery. OTS consists of two software parts: - Ortoma Hip Plan OHP, a 3D preoperative planning application . - . Ortoma Hip Guide - OHG, provides real-time navigation for guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal position OHP has support for PACS (Picture Archiving Communication System) solutions already available at Hospitals. The PACS system handles the DICOM (Digital Imaging and Communications in Medicine) data obtained from Computed Tomography (CT) scans of patients. DICOM data from the PACS system is uploaded into the OHP and an illustrative 3D image of the unique patient´s anatomy is created. The OHP application includes functions to define the measurements of the individual patient anatomy, such as the offset, anteversion and leg length. The surgeon selects prosthetic components in relation to the anatomy data and measurements obtained in the application, to virtually decide the position of the prosthetic components. The OHG application functions as a positioning system in relation to the preoperatively planned goal position. The system includes passive retro-reflective markers with camera, monitor and adapters to attach the passive retro-reflective markers to surgical instruments. The OHG gives the surgeon real-time positioning information, while the orthopedic surgeon positions the surgical instruments and prosthetic components during the implant surgery, in relation to the patient anatomy as previously planned. The surgeons decide based on their clinical knowledge and experience how the surgery should be performed. The OTS is compatible with the following Stryker components: Stryker Asnis III 4.0x20 mm full thread stainless steel, Stryker Holding Sleeve for Screwdrivers, Stryker Cannulated Screwdriver with AO Coupling - Hex 2.5mm, Stryker Ortholock Ex-Pin 150x4 mm screw, Stryker quick release apex, Stryker Reamer, and Stryker Cup Inserter.