# K163323: Dolphix® External Fixation System MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Citieffe S.R.L.
- Decided: Mar 20, 2017 after 115 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for: - Temporary stabilization of open or closed acute fractures with soft tissue injuries; - Temporary stabilization of fractures in the context of polytrauma; - Temporary stabilization of certain pelvic fractures or pelvic ring injuries; - Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure; - Temporary stabilization of non-unions; - Intra-operative temporary stabilization tool to assist with indirect reduction. Dolphix® External Fixation System MR Conditional is intended for use in a non-weight bearing patient.

Source page: https://510kreport.com/device/K163323
Methodology: https://510kreport.com/methodology