TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
FDA 510(k) K173811 · In2bones Sas
510(k) numberK173811
Submission
- Device name
- TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
- Applicant
- In2bones Sas
Ecully, FR - Received
- December 15, 2017
- Decision date
- March 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/23/2024SE |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/06/2023SE |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 08/11/2021SE |
| K191380 | Quantum® Total Ankle ProsthesisHSN · Traditional | 01/29/2020SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | 01/19/2018SE |
| K173121 | Ankle Fusion Plating SystemHRS · Traditional | 11/28/2017SE |
| K170688 | PITStop® implantHWC · Traditional | 11/28/2017SE |
| K170594 | I.B.S. osteosynthesis screwsHWC · Special | 05/10/2017SE |
| K160174 | I.B.S. 2.0 Osteosynthesis screwHWC · Traditional | 10/06/2016SE |
| K160995 | NEOVIEW Plating SystemHRS · Traditional | 06/10/2016SE |
Questions and answers
When was TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System cleared by the FDA?
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System (K173811) received a 510(k) decision of Substantially Equivalent on March 15, 2018, 90 days after the submission was received.
What is the product code of K173811?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.