Orthopedics
Signature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS
FDA-cleared AI medical device
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
FDA Submission Metadata
- Submission number
- K260104
- Decision date
- February 2026
- FDA panel
- Orthopedic
- Product code
- QHE
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.