Shoulder Arthroplasty Implantation System
FDA product code QHE · Class II (moderate risk) · 21 CFR 888.3660 · 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.
26510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 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 |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | Materialise NV | 05/22/2024SE |
| K232425 | Signature ONE SystemQHE · Traditional | Orthosoft Inc. (D/B/A) Zimmer Cas) | 12/12/2023SE |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | Materialise NV | 11/09/2023SE |
| K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | Materialise NV | 09/12/2023SE |
| K230904 | Arthrex Virtual Implant Positioning (VIP) SystemQHE · Traditional | Arthrex, Inc. | 06/22/2023SE |
| K222007 | Arthrex Virtual Implant Positioning (VIP) SystemQHE · Traditional | Arthrex, Inc. | 03/08/2023SE |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder…QHE · Special | Materialise NV | 03/06/2023SE |
| K222405 | Smart SPACE Shoulder Planner and 3D PositionersQHE · Traditional | Lima Corporate S.P.A. | 12/20/2022SE |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…QHE · Traditional | Materialise NV | 08/17/2022SE |
| K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | Materialise NV | 01/12/2022SE |
| K212560 | Signature ONE SystemQHE · Traditional | Orthosoft Inc (D/B/A Zimmer Cas) | 10/12/2021SE |
| K202151 | Smart SPACE Shoulder SystemQHE · Traditional | Techmah Medical, LLC | 02/03/2021SE |
| K202454 | Smart SPACE Shoulder SystemQHE · Traditional | Techmah Medical, LLC | 12/28/2020SE |
| K200615 | Signature ONE SystemQHE · Traditional | Orthosoft Inc (D/B/A Zimmer Cas) | 06/05/2020SE |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…QHE · Traditional | Materialise NV | 03/20/2020SE |
| K192074 | Signature ONE SystemQHE · Special | Orthosoft Inc (D/B/A Zimmer Cas) | 08/30/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1810-2026 Class II | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu… | Linkbio Corp. | 03/12/2026Open, Classified |
| Z-2291-2021 Class II | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a)…Potential patient exposure to the graphite substrate. | Tornier S.A.S. | 06/25/2021Open, Classified |