Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
FDA 510(k) K233408 · Materialise NV
510(k) numberK233408
Submission
- Device name
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Applicant
- Materialise NV
Leuven, BE - Received
- October 6, 2023
- Decision date
- November 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHE – Shoulder Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
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.
Other 510(k)s with product code QHE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | Materialise NV | 06/09/2026SE |
| K261510 | Signature ONE SystemQHE · Special | Orthosoft Inc. (d/b/a) Zimmer CAS | 06/04/2026SE |
| K260104 | Signature ONE SystemQHE · Special | Orthosoft Inc. (d/b/a) Zimmer CAS | 02/04/2026SE |
| K251558 | Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional | Precision AI Pty, Ltd. | 01/12/2026SE |
| K243509 | Archer PSI SystemQHE · Traditional | 3D-Side | 05/12/2025SE |
| K241470 | CORE Shoulder SystemQHE · Traditional | LinkBio Corp. | 02/20/2025SE |
| K243955 | Precision AI Surgical Planning System (PAI-SPS)QHE · Special | Precision AI Pty, Ltd. | 01/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | Materialise NV | 10/18/2024SE |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System SoftwareQHE · Traditional | Arthrex, Inc. | 10/02/2024SE |
| K233992 | Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional | Precision AI Pty, Ltd. | 08/05/2024SE |
More from Precision AI Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 06/09/2026SE |
| K251964 | Mimics Thoracic PlannerLLZ · Traditional | 03/12/2026SE |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | 01/07/2026SE |
| K253793 | Materialise TKA Guide SystemJWH · Special | 01/06/2026SE |
| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 10/18/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | 05/31/2024SE |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 05/22/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
Questions and answers
When was Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner cleared by the FDA?
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408) received a 510(k) decision of Substantially Equivalent on November 9, 2023, 34 days after the submission was received.
What is the product code of K233408?
The FDA product code is QHE – Shoulder Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.