510(k) K251558
K251558 is an FDA 510(k) premarket notification submitted by Precision AI Pty, Ltd. for the device "Precision AI Surgical Planning System (PAI-SPS)". The FDA issued a decision of Substantially Equivalent on January 12, 2026. The device falls under product code QHE (Shoulder Arthroplasty Implantation System), a Class II device regulated under 21 CFR 888.3660. Precision AI Pty, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2026
- Date Received
- May 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoulder Arthroplasty Implantation System
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
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.