Inbone Total Ankle
FDA 510(k) K133585 · Wrightmedicaltechnologyinc
510(k) numberK133585
Submission
- Device name
- Inbone Total Ankle
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- November 21, 2013
- Decision date
- February 20, 2014
- 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 |
|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment SystemHSN · Traditional | 01/27/2023SE |
| K213342 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 01/05/2022SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
| K183620 | PROSTEP TBC Implant SystemHRS · Traditional | 06/06/2019SE |
Questions and answers
When was Inbone Total Ankle cleared by the FDA?
Inbone Total Ankle (K133585) received a 510(k) decision of Substantially Equivalent on February 20, 2014, 91 days after the submission was received.
What is the product code of K133585?
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.