Vantage PSI System
FDA 510(k) K193432 · 3D Systems
510(k) numberK193432
Submission
- Device name
- Vantage PSI System
- Applicant
- 3D Systems
Littleton, CO, US - Received
- December 10, 2019
- Decision date
- November 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYK – Ankle Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3110
- Specialty
- Orthopedic
Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Other 510(k)s with product code OYK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243174 | Cadence Ankle PSI SystemOYK · Special | 3D Systems, Inc. | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 3D Systems, Inc. | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 3D Systems, Inc. | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 3D Systems, Inc. | 08/30/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 3D Systems, Inc. | 06/30/2023SE |
| K223326 | Axiom PSR SystemOYK · Traditional | Restor3D | 03/30/2023SE |
More from Restor3D
| 510(k) | Device | Decision |
|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 06/03/2026SE |
| K250711 | VSP Orthopedics SystemPBF · Traditional | 12/05/2025SE |
| K243174 | Cadence Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 04/04/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
Questions and answers
When was Vantage PSI System cleared by the FDA?
Vantage PSI System (K193432) received a 510(k) decision of Substantially Equivalent on November 9, 2020, 335 days after the submission was received.
What is the product code of K193432?
The FDA product code is OYK – Ankle Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3110.