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FDA-cleared K260077

OrthoGrid Hip AI® 4.0

OrthoGrid Systems, Inc.

Authorized purpose: OrthoGrid Hip AI 4.0 analyzes two-dimensional C-arm fluoroscopic images to assist positioning of hip-replacement components during direct-anterior total hip arthroplasty.

Modality
Fluoroscopy/Angiography
Anatomy
Hip
Decision
2026-05-29
FDA-cleared K192279

PhantomMSK Trauma

OrthoGrid Systems Inc.

Authorized purpose: Supports intraoperative positioning of orthopedic-trauma components.

Modality
Fluoroscopy/Angiography
Anatomy
MSK
Decision
2019-12-07