QHE — Shoulder Arthroplasty Implantation System Class II
FDA product code QHE covers "Shoulder Arthroplasty Implantation System", a Class II medical device regulated under 21 CFR 888.3660. Submissions are reviewed by the Orthopedic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QHE
- Device Class
- Class II
- Regulation Number
- 888.3660
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260802 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | June 9, 2026 |
| K261510 | orthosoft inc. (d/b/a) zimmer cas | Signature ONE System | June 4, 2026 |
| K260104 | orthosoft inc. (d/b/a) zimmer cas | Signature ONE System | February 4, 2026 |
| K251558 | precision ai pty | Precision AI Surgical Planning System (PAI-SPS) | January 12, 2026 |
| K243509 | 3d-side | Archer PSI System | May 12, 2025 |
| K241470 | linkbio | CORE Shoulder System | February 20, 2025 |
| K243955 | precision ai pty | Precision AI Surgical Planning System (PAI-SPS) | January 21, 2025 |
| K242813 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | October 18, 2024 |
| K241097 | arthrex | Arthrex Virtual Implant Positioning (VIP) System Software | October 2, 2024 |
| K233992 | precision ai pty | Precision AI Surgical Planning System (PAI-SPS) | August 5, 2024 |
| K241143 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | May 22, 2024 |
| K232425 | orthosoft inc. (d/b/a) zimmer cas) | Signature ONE System | December 12, 2023 |
| K233408 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | November 9, 2023 |
| K231112 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | September 12, 2023 |
| K230904 | arthrex | Arthrex Virtual Implant Positioning (VIP) System | June 22, 2023 |
| K222007 | arthrex | Arthrex Virtual Implant Positioning (VIP) System | March 8, 2023 |
| K230315 | materialise | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Sho | March 6, 2023 |
| K222405 | lima corporate | Smart SPACE Shoulder Planner and 3D Positioners | December 20, 2022 |
| K220452 | materialise | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Sh | August 17, 2022 |
| K212569 | materialise | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S | January 12, 2022 |