Integra Salto Total Ankle System
FDA 510(k) K182878 · Ascension Orthopedics
510(k) numberK182878
Submission
- Device name
- Integra Salto Total Ankle System
- Applicant
- Ascension Orthopedics
Austin, TX, US - Received
- October 15, 2018
- Decision date
- December 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | 05/30/2024SE |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | 12/14/2023SE |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
| K110700 | Ascension Atlas Humeral Plating SystemHRS · Traditional | 12/06/2011SE |
Questions and answers
When was Integra Salto Total Ankle System cleared by the FDA?
Integra Salto Total Ankle System (K182878) received a 510(k) decision of Substantially Equivalent on December 18, 2018, 64 days after the submission was received.
What is the product code of K182878?
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.