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FDA-cleared K241696

Ortho AI

Ortho AI LLC

Authorized purpose: Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion workflows, with editable overlays for adult orthopedic review; it is not primary interpretation or mobile use.

Modality
X-ray/Radiography
Anatomy
Pelvis, knee, and lumbar spine
Decision
2025-01-02