MySpine WebPlanner

MySpine WebPlanner is a web-based surgical planning software that processes patient radiological images (DICOM format) to assist orthopedic and neurosurgeons in preoperative planning for spinal fixation and fusion procedures. The software enables viewing, storing, and measuring radiological images, and allows surgeons to plan implant size and positioning for spinal fixation and fusion devices (including cages) in both skeletally mature and immature patients.

The subject device is identical to the predicate (K211386) in hardware (laptop/PC/tablet), operating system independence (web application), image input (DICOM), design (Chrome/Firefox accessible web app), database storage (Medacta server), user interface (GUI), and workflow. The primary difference is the addition of cage planning capability to the surgical planning output, which now includes screw and cage planning parameters in addition to the predicate's screw-only planning.

Not stated in this summary.

The addition of cage planning functionality does not introduce different questions of safety and effectiveness compared to the predicate because both devices serve the same preoperative surgical planning purpose and use identical underlying technology, workflow, and hardware infrastructure. Software verification and validation studies were performed to confirm that the new cage planning module integrates safely with the existing system. The cage planning feature is a logical and incremental expansion of the device's intended use rather than a fundamental change in how the device operates or what risks it presents.