# K150661: ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite

- Pathway: 510(k) (Traditional)
- Applicant: Citieffe S.R.L.
- Decided: Jul 7, 2015 after 116 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K162032: Arrowhead Mini-Rail Fixator (2017), 1 descendant of its own
- K252106: External Fixation Mini Rail System (2025), 0 descendants of its own

## Indications for use
Citieffe External Fixator ST.A.R 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; - Post traumatic reconstruction for joint stiffness. Citieffe External Fixator ST.AR. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotornies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K150661
Methodology: https://510kreport.com/methodology
