Kinos Total Ankle System
FDA 510(k) K242868 · Restor3D
510(k) numberK242868
Submission
- Device name
- Kinos Total Ankle System
- Applicant
- Restor3D
Durham, NC, US - Received
- September 20, 2024
- Decision date
- October 18, 2024
- 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 |
| 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 |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | In2bones Sas | 04/23/2024SE |
More from In2bones Sas
| 510(k) | Device | Decision |
|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | 07/01/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | 05/07/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | 12/05/2025SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | 09/03/2025SE |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty SystemPHX · Traditional | 05/19/2025SE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement SystemMBH · Traditional | 03/27/2025SE |
| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | 03/24/2025SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | 07/22/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | 04/29/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | 01/22/2024SE |
Questions and answers
When was Kinos Total Ankle System cleared by the FDA?
Kinos Total Ankle System (K242868) received a 510(k) decision of Substantially Equivalent on October 18, 2024, 28 days after the submission was received.
What is the product code of K242868?
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.