Panels › Orthopedic › Product code QHE · Class 2
Shoulder Arthroplasty Implantation System
Regulation 888.3660
4510(k)s in 12 months (26 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in QHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Materialise NV | 9 | 0 |
| Orthosoft Inc (D/B/A Zimmer Cas) | 6 | 0 |
| Arthrex, Inc. | 3 | 0 |
| Precision AI Pty, Ltd. | 3 | 0 |
| LinkBio Corp. | 1 | 1 |
| Techmah Medical, LLC | 2 | 0 |
| 3D-Side | 1 | 0 |
| Lima Corporate S.P.A. | 1 | 0 |
| Tornier S.A.S. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2026 | K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Jun 4, 2026 | K261510 | Signature ONE System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | QHE |
| Feb 4, 2026 | K260104 | Signature ONE System Orthosoft Inc. (d/b/a) Zimmer CAS, CA | QHE |
| Jan 12, 2026 | K251558 | Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty, Ltd., AU | QHE |
| May 12, 2025 | K243509 | Archer PSI System 3D-Side, BE | QHE |
| Feb 20, 2025 | K241470 | CORE Shoulder System LinkBio Corp. | QHE |
| Jan 21, 2025 | K243955 | Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty, Ltd., AU | QHE |
| Oct 18, 2024 | K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Oct 2, 2024 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software Arthrex, Inc. | QHE |
| Aug 5, 2024 | K233992 | Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty, Ltd., AU | QHE |
| May 22, 2024 | K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Dec 12, 2023 | K232425 | Signature ONE System Orthosoft Inc. (D/B/A) Zimmer Cas), CA | QHE |
| Nov 9, 2023 | K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Sep 12, 2023 | K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Jun 22, 2023 | K230904 | Arthrex Virtual Implant Positioning (VIP) System Arthrex, Inc. | QHE |
| Mar 8, 2023 | K222007 | Arthrex Virtual Implant Positioning (VIP) System Arthrex, Inc. | QHE |
| Mar 6, 2023 | K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Dec 20, 2022 | K222405 | Smart SPACE Shoulder Planner and 3D Positioners Lima Corporate S.P.A., IT | QHE |
| Aug 17, 2022 | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Jan 12, 2022 | K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Oct 12, 2021 | K212560 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
| Feb 3, 2021 | K202151 | Smart SPACE Shoulder System Techmah Medical, LLC | QHE |
| Dec 28, 2020 | K202454 | Smart SPACE Shoulder System Techmah Medical, LLC | QHE |
| Jun 5, 2020 | K200615 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
| Mar 20, 2020 | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase S Materialise NV, BE | QHE |
| Aug 30, 2019 | K192074 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | QHE |
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