Product code QHE
- Device name
- Shoulder Arthroplasty Implantation System
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3660
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026-01-12 |
| K243509 | Archer PSI System | 3D-Side | 2025-05-12 |
| K241470 | CORE Shoulder System | LinkBio Corp. | 2025-02-20 |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025-01-21 |
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-10-18 |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024-10-02 |
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024-08-05 |
| K241143 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-05-22 |
| K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 |
| K233408 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-11-09 |
| K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-09-12 |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-06-22 |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-03-08 |
| K230315 | Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | 2023-03-06 |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022-12-20 |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | 2022-08-17 |
| K212569 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2022-01-12 |
| K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021-10-12 |
| K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021-02-03 |
| K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020-12-28 |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020-06-05 |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | Materialise NV | 2020-03-20 |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630542730153 | MyShoulder Planner | Medacta International SA | 2025-02-06 |
| 00887868554391 | Signature™ Comprehensive® | Orthosoft Inc | 2024-02-09 |
| 00887868554407 | Signature™ Comprehensive® | Orthosoft Inc | 2024-02-09 |
| 00888867409668 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867409613 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867392311 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867392298 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867392281 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867392267 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867392250 | Arthrex® | ARTHREX, INC. | 2023-04-24 |
| 00888867315501 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315334 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315341 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315358 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315365 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315372 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315389 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315396 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315525 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315518 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315402 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315495 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315488 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315471 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315464 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315457 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315440 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315433 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315426 | Arthrex® | ARTHREX, INC. | 2020-02-14 |
| 00888867315419 | Arthrex® | ARTHREX, INC. | 2020-02-14 |