Cleared Traditional

Precision AI Surgical Planning System (PAI-SPS)

K251558 · Precision AI Pty, Ltd. · Orthopedic

Jan 2026

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K251558 is an FDA 510(k) clearance for the Precision AI Surgical Planning System (PAI-SPS), a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Precision AI Pty, Ltd. (Fortitude Valley, AU). The FDA issued a Cleared decision on January 12, 2026, 236 days after receiving the submission on May 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K251558 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2025
Decision Date	January 12, 2026
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	QHE — Shoulder Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	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.