Archer PSI System
FDA 510(k) K243509 · 3D-Side
510(k) numberK243509
Submission
- Device name
- Archer PSI System
- Applicant
- 3D-Side
Mont-Saint-Guibert, BE - Received
- November 12, 2024
- Decision date
- May 12, 2025
- 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 |
| 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 |
Questions and answers
When was Archer PSI System cleared by the FDA?
Archer PSI System (K243509) received a 510(k) decision of Substantially Equivalent on May 12, 2025, 181 days after the submission was received.
What is the product code of K243509?
The FDA product code is QHE – Shoulder Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.