4 devices · 3 companies · 2024 to 2026
Product code QHE: Shoulder Arthroplasty Implantation System
4 devices under product code QHE, 2024 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Shoulder Arthroplasty Implantation System. 21 CFR 888.3660, Class II. 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. MAUDE held 8 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Signature ONE SystemK260104 · 510(k) | Orthosoft Inc. (d/b/a) Zimmer CAS | Orthopedic | database entry | |
| Precision AI Surgical Planning SystemK251558 · 510(k) | Precision AI Pty, Ltd. | Orthopedic | database entry | |
| Precision AI Surgical Planning SystemK243955 · 510(k) | Precision AI Pty Ltd | Orthopedic | database entry | |
| Precision AI Surgical Planning SystemK233992 · 510(k) | Precision AI Pty Ltd | Orthopedic | database entry |
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