# QHE: Shoulder Arthroplasty Implantation System

- Device class: 2; regulation: 21 CFR 888.3660; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 140 days (middle half 41–181)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2019: 1
- 2020: 3
- 2021: 2
- 2022: 3
- 2023: 6
- 2024: 4
- 2025: 3
- 2026: 4

## Most-cited predicates
- K242813: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2024), cited by 3
- K212560: Signature™ ONE System (2021), cited by 2
- K220452: Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (2022), cited by 2
- K222007: Arthrex Virtual Implant Positioning (VIP) System (2023), cited by 2
- K193560: Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (2020), cited by 2
- K212569: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2022), cited by 2
- K200615: Signature ONE System (2020), cited by 1
- K233992: Precision AI Surgical Planning System (PAI-SPS) (2024), cited by 1
- K192074: Signature ONE System (2019), cited by 1
- K202151: Smart SPACE Shoulder System (2021), cited by 1

Source page: https://510kreport.com/product-code/QHE
Data by year (CSV): https://510kreport.com/product-code/QHE.csv