AI devices with FDA product code QHE — Shoulder Arthroplasty Implantation System
Product code QHE (“Shoulder Arthroplasty Implantation System” in openFDA) covers 4 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Orthopedic panel (4). The most recent decision was Signature ONE System on February 4, 2026.
4AI devices
2Companies
2024First decision
2026-02-04Latest decision
Trend: devices per year
202420252026
Top companies
All 4 devices, newest first
- Signature ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty Ltd · Orthopedic
- Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty Ltd · Orthopedic