FDA product code QHE: Shoulder Arthroplasty Implantation System
QHE is the FDA product code for shoulder arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 26 510(k) submissions under QHE, 20 in the last five years, from 10 different applicants. The average 510(k) review took 115 days (median 106); 123 days on average over the last three years. FDA has posted 2 recalls for QHE devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Shoulder Arthroplasty Implantation System |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QHE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 28 |
| 2020 | 3 | 100 |
| 2021 | 2 | 122 |
| 2022 | 3 | 154 |
| 2023 | 6 | 110 |
| 2024 | 4 | 113 |
| 2025 | 3 | 161 |
| 2026 | 4 | 94 |
Compare with all 510(k) review times · Search every QHE clearance
Top QHE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Materialise NV | 9 | 2026-06-09 |
| Precision AI Pty, Ltd. | 3 | 2026-01-12 |
| Arthrex, Inc. | 3 | 2024-10-02 |
| Orthosoft Inc (D/B/A Zimmer Cas) | 3 | 2021-10-12 |
| Orthosoft Inc. (d/b/a) Zimmer CAS | 2 | 2026-06-04 |
5 more applicants have QHE clearances. See the full list in Caduvo.
Most recent QHE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260802 | Materialise NV | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 2026-06-09 | 90 |
| K261510 | Orthosoft Inc. (d/b/a) Zimmer CAS | Signature ONE System | 2026-06-04 | 28 |
| K260104 | Orthosoft Inc. (d/b/a) Zimmer CAS | Signature ONE System | 2026-02-04 | 22 |
| K251558 | Precision AI Pty, Ltd. | Precision AI Surgical Planning System (PAI-SPS) | 2026-01-12 | 236 |
| K243509 | 3D-Side | Archer PSI System | 2025-05-12 | 181 |
Recalls for QHE devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2026-03-12.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QHE?
QHE is the FDA product code for shoulder arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is QHE?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHE?
Across 26 cleared submissions the average was 115 days from receipt to decision (median 106).
Which companies have the most QHE clearances?
Materialise NV (9); Precision AI Pty, Ltd. (3); Arthrex, Inc. (3); Orthosoft Inc (D/B/A Zimmer Cas) (3); Orthosoft Inc. (d/b/a) Zimmer CAS (2).
Have QHE devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-03-12.
Next steps
- Run an FDA pathway report with predicate devices for product code QHE
- Run a recall and safety report across every QHE manufacturer
- Watch product code QHE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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