Computer-Assisted Navigation for Orthopedic Procedures

Covers intraoperative computer‑assisted navigation systems (image‑ or non‑image‑based) used to guide implant positioning, bone cuts, screw placement, and acquisition of anatomic/kinematic data in orthopedic procedures — commonly applied in total knee arthroplasty, fracture fixation (e.g., femoral neck screws), ACL reconstruction, acetabular cup placement, minimally invasive procedures, and tumor resections. Major limitations: many uses are considered investigational or not covered (robot‑performed surgeries such as MAKOplasty excluded), spinal navigation is not addressed here, systems are typically FDA 510(k)‑cleared rather than PMA, and evidence is insufficient to demonstrate improved long‑term clinical outcomes, requiring further controlled studies with longer follow‑up.

"Reduce the risk of substantial malalignment in orthopedic procedures"

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