Signature ONE System
FDA 510(k) K212560 · Orthosoft Inc (D/B/A Zimmer Cas)
510(k) numberK212560
Submission
- Device name
- Signature ONE System
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
Montreal, CA - Received
- August 13, 2021
- Decision date
- October 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHE – Shoulder Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- 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.
Other 510(k)s with product code QHE
| 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 |
More from Precision AI Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261510 | Signature ONE SystemQHE · Special | 06/04/2026SE |
| K260582 | ROSA® Shoulder SystemOLO · Traditional | 05/21/2026SE |
| K260104 | Signature ONE SystemQHE · Special | 02/04/2026SE |
| K251314 | Rosa® Knee SystemOLO · Traditional | 11/13/2025SE |
| K242864 | ROSA® Knee SystemOLO · Special | 10/18/2024SE |
| K233199 | ROSA® Shoulder SystemOLO · Traditional | 02/21/2024SE |
| K232425 | Signature ONE SystemQHE · Traditional | 12/12/2023SE |
| K230567 | OptiVu ROSA® MxRSBF · Traditional | 06/13/2023SE |
| K231162 | ROSA Hip SystemLLZ · Special | 05/23/2023SE |
| K230180 | Rosa Knee SystemOLO · Special | 02/22/2023SE |
Questions and answers
When was Signature ONE System cleared by the FDA?
Signature ONE System (K212560) received a 510(k) decision of Substantially Equivalent on October 12, 2021, 60 days after the submission was received.
What is the product code of K212560?
The FDA product code is QHE – Shoulder Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.