510(k) · Cleared

Cleared

ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite

K150661510(k) TraditionalCleared Jul 7, 2015116-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Citieffe S.R.L. · JDW Pin, Fixation, Threaded

Cleared on Jul 7, 2015 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Jul 7, 2015
Review: 116 days
Class: Class II
Product code: JDW
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK150661 ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteCitieffe S.R.L. · 2015
Descendant · cites it directly · 1 of its ownK162032 Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017
Descendant · 2 generations on · 0 of its ownK252106 External Fixation Mini Rail SystemParagon 28, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all

K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC · 2017 · cites it directly1descendant
K252106External Fixation Mini Rail SystemParagon 28, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K150661	ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite	Citieffe S.R.L.	2015	—
+1	K162032	Arrowhead Mini-Rail Fixator	Arrowhead De, LLC	2017	—
+2	K252106	External Fixation Mini Rail System	Paragon 28, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2025	1	0

FIG. 1 — Lineage of K150661, 2015–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JDW device

#1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K162032	Arrowhead Mini-Rail Fixator	Arrowhead De, LLC	2017	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K162032 (Arrowhead De, LLC, 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JDW

2in 2025

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDW

Too few JDW 510(k)s in any year since 2007 to give a median.

Recalls per year · JDW

21in 2018

2007high 52 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDW

29in 2025

2007high 575 (2019) · low 25 (2007)2025

MAUDE reports naming product code JDW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	25
2008	0	—	0	26
2009	1	—	2	29
2010	2	—	2	29
2011	1	—	0	55
2012	1	—	52	75
2013	2	—	0	69
2014	2	—	0	27
2015	1	—	0	70
2016	0	—	0	46
2017	1	—	2	43
2018	1	—	21	94
2019	1	—	0	575
2020	2	—	0	402
2021	2	—	0	168
2022	2	—	0	121
2023	0	—	0	72
2024	0	—	0	65
2025	2	—	0	29
2026	1	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K150661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150661: ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150661

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026