Orthopedics
United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
FDA-cleared AI medical device
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
FDA Submission Metadata
- Submission number
- K230850
- Decision date
- December 2023
- FDA panel
- Orthopedic
- Product code
- OOG
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
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.