QUANTUM® Patient Specific Instrumentation (PSI) System
FDA 510(k) K231699 · In2bones Sas
510(k) numberK231699
Submission
- Device name
- QUANTUM® Patient Specific Instrumentation (PSI) System
- Applicant
- In2bones Sas
Ecully, FR - Received
- June 12, 2023
- Decision date
- April 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSN – Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3110
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning SystemHSN · Traditional | Wright Medical Technology, Inc. (Stryker) | 06/16/2026SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | Restor3D | 09/03/2025SE |
| K250037 | Incompass Total Ankle SystemHSN · Traditional | Wright Medical Technology, Inc. (Stryker) | 06/20/2025SE |
| K250641 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | Paragon 28, Inc. | 05/01/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | Vilex, LLC | 12/02/2024SE |
| K241999 | Prophecy Surgical Planning SystemHSN · Traditional | Wright Medical Technology, Inc. (Stryker) | 11/01/2024SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | Restor3D | 10/18/2024SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | Restor3D | 07/22/2024SE |
| K240259 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | Paragon 28, Inc. | 06/24/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | Restor3D, Inc. | 04/29/2024SE |
More from Restor3D, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/06/2023SE |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 08/11/2021SE |
| K191380 | Quantum® Total Ankle ProsthesisHSN · Traditional | 01/29/2020SE |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemHSB · Traditional | 03/15/2018SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | 01/19/2018SE |
| K173121 | Ankle Fusion Plating SystemHRS · Traditional | 11/28/2017SE |
| K170688 | PITStop® implantHWC · Traditional | 11/28/2017SE |
| K170594 | I.B.S. osteosynthesis screwsHWC · Special | 05/10/2017SE |
| K160174 | I.B.S. 2.0 Osteosynthesis screwHWC · Traditional | 10/06/2016SE |
| K160995 | NEOVIEW Plating SystemHRS · Traditional | 06/10/2016SE |
Questions and answers
When was QUANTUM® Patient Specific Instrumentation (PSI) System cleared by the FDA?
QUANTUM® Patient Specific Instrumentation (PSI) System (K231699) received a 510(k) decision of Substantially Equivalent on April 23, 2024, 316 days after the submission was received.
What is the product code of K231699?
The FDA product code is HSN – Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3110.