QHE — Shoulder Arthroplasty Implantation System Class II
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 |
|---|---|---|---|
| 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 |
| K212560 | orthosoft inc (d/b/a zimmer cas) | Signature ONE System | October 12, 2021 |
| K202151 | techmah medical | Smart SPACE Shoulder System | February 3, 2021 |