Incompass Total Ankle System
FDA 510(k) K250037 · Wright Medical Technology, Inc. (Stryker)
510(k) numberK250037
Submission
- Device name
- Incompass Total Ankle System
- Applicant
- Wright Medical Technology, Inc. (Stryker)
Memphis, TN, US - Received
- January 8, 2025
- Decision date
- June 20, 2025
- 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 |
| 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 |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | In2bones Sas | 04/23/2024SE |
More from In2bones Sas
| 510(k) | Device | Decision |
|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning SystemHSN · Traditional | 06/16/2026SE |
| K251643 | Synchfix EVTHTN · Traditional | 10/29/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | 09/30/2025SE |
| K241999 | Prophecy Surgical Planning SystemHSN · Traditional | 11/01/2024SE |
Questions and answers
When was Incompass Total Ankle System cleared by the FDA?
Incompass Total Ankle System (K250037) received a 510(k) decision of Substantially Equivalent on June 20, 2025, 163 days after the submission was received.
What is the product code of K250037?
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.