Product code QHE— Orthopedic
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Classification name
- Shoulder Arthroplasty Implantation System
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Total cleared
- 26
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QHE
FDA has cleared devices under product code QHE between 2019 and 2026, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
Top applicants under product code QHE
Recent clearances under product code QHE
- K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K261510 — Signature ONE System
- K260104 — Signature ONE System
- K251558 — Precision AI Surgical Planning System (PAI-SPS)
- K243509 — Archer PSI System
- K241470 — CORE Shoulder System
- K243955 — Precision AI Surgical Planning System (PAI-SPS)
- K242813 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K241097 — Arthrex Virtual Implant Positioning (VIP) System Software
- K233992 — Precision AI Surgical Planning System (PAI-SPS)
- K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K232425 — Signature ONE System
- K233408 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K231112 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K230904 — Arthrex Virtual Implant Positioning (VIP) System
- K222007 — Arthrex Virtual Implant Positioning (VIP) System
- K230315 — Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
- K222405 — Smart SPACE Shoulder Planner and 3D Positioners
- K220452 — Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
- K212569 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K212560 — Signature ONE System
- K202151 — Smart SPACE Shoulder System
- K202454 — Smart SPACE Shoulder System
- K200615 — Signature ONE System
- K193560 — Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
- K192074 — Signature ONE System
Data sourced from openFDA. This site is unofficial and independent of the FDA.