Exactech® Vantage® Total Ankle System
FDA 510(k) K230717 · Exactech, Inc.
510(k) numberK230717
Submission
- Device name
- Exactech® Vantage® Total Ankle System
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- March 15, 2023
- Decision date
- October 12, 2023
- 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 |
|---|---|---|
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | 04/14/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | 12/01/2025SE |
| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | 08/01/2025SE |
| K243275 | Equinoxe® Scapula Fracture SystemHRS · Traditional | 06/26/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | 03/10/2025SE |
| K240393 | Exactech® TRULIANT® Knee SystemMBH · Traditional | 10/03/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | 07/18/2024SE |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional | 09/25/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | 09/14/2023SE |
| K232002 | Vantage® Total Ankle SystemHSN · Traditional | 09/11/2023SE |
Questions and answers
When was Exactech® Vantage® Total Ankle System cleared by the FDA?
Exactech® Vantage® Total Ankle System (K230717) received a 510(k) decision of Substantially Equivalent on October 12, 2023, 211 days after the submission was received.
What is the product code of K230717?
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.