OTS Hip

OTS Hip is a surgical navigation system that helps orthopedic surgeons plan and perform total hip replacement procedures. It uses CT and X-ray imaging to create a 3D model of the patient's anatomy and provides real-time intraoperative guidance to position prosthetic components accurately during posterior approach hip arthroplasty.

The subject device adds X-ray imaging capability and extended pre-processing with patient-specific configuration for initial cup angle planning, compared to the predicate which used only CT imaging. Both devices use the same workflow for landmark detection, segmentation via fixed machine learning algorithms, and real-time optical tracking for navigation. Minor hardware changes include updated calibration adapters, improved tool interfaces, and compatibility with additional Kincise surgical instruments.

IEC 60601-1 Edition 3.2 2020-08 and IEC 60601-1-2:2014 [AMD 1:2021] for electrical safety and EMC; ISO 10993 for biocompatibility; ASTM F2554-18 for localization and tracking accuracy; ISO 14971:2019 for risk management.

The subject device has identical intended use, indications, user population, anatomical site, and technological principle of operation as the predicate K232140. Both enable pre-operative planning and intraoperative navigated surgery using similar hardware and ML-based segmentation. The addition of X-ray imaging and patient-specific configuration uses an algorithm component previously cleared in K231503. Performance testing on 90 CT datasets and 503 X-ray images demonstrated equivalent accuracy in inclination, anteversion, and position error. All differences—including expanded imaging capability, minor hardware refinements, and new tool compatibility—do not raise new safety or effectiveness questions.