Arthrex DualCompression Hindfoot Fusion Nail Implant System
FDA 510(k) K221031 · Arthrex, Inc.
510(k) numberK221031
Submission
- Device name
- Arthrex DualCompression Hindfoot Fusion Nail Implant System
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- April 7, 2022
- Decision date
- December 20, 2022
- 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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| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was Arthrex DualCompression Hindfoot Fusion Nail Implant System cleared by the FDA?
Arthrex DualCompression Hindfoot Fusion Nail Implant System (K221031) received a 510(k) decision of Substantially Equivalent on December 20, 2022, 257 days after the submission was received.
What is the product code of K221031?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.