Dolphix® External Fixation System MR Conditional
FDA 510(k) K163323 · Citieffe S.R.L.
510(k) numberK163323
Submission
- Device name
- Dolphix® External Fixation System MR Conditional
- Applicant
- Citieffe S.R.L.
Calderara Di Reno, IT - Received
- November 25, 2016
- Decision date
- March 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250197 | Estremo Fibular NailHSB · Traditional | 10/17/2025SE |
| K183666 | EBA One Nailing SystemHSB · Traditional | 11/14/2019SE |
| K181540 | Estremo Citieffe Nailing SystemHSB · Traditional | 01/16/2019SE |
| K180150 | PL8 Wrist Reconstruction PlateHRS · Traditional | 08/02/2018SE |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteJDW · Traditional | 07/07/2015SE |
| K132363 | Dolphix External Fixation SystemKTT · Traditional | 01/16/2014SE |
| K131005 | EBA2 Femoral Nailing SystemHSB · Special | 06/25/2013SE |
Questions and answers
When was Dolphix® External Fixation System MR Conditional cleared by the FDA?
Dolphix® External Fixation System MR Conditional (K163323) received a 510(k) decision of Substantially Equivalent on March 20, 2017, 115 days after the submission was received.
What is the product code of K163323?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.