510(k) · Cleared

Cleared

Modification to Jet-X HA Coated Half Pins

K033289510(k) SpecialCleared Jan 13, 200491-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

Smith & Nephew, Inc. · JDW Pin, Fixation, Threaded

Cleared on Jan 13, 2004 as substantially equivalent to K023921 (Smith & Nephew, Inc., 2003) after a 91-day review. Its family tree reaches back 3 generations to 1995. 49 later devices descend from it.

Decided: Jan 13, 2004
Review: 91 days
Class: Class II
Product code: JDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K953397 (1995). 49 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
2 generations backK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
1 generation backK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · Recalled
This deviceK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
Descendant · cites it directly · 34 of its ownK050849 HA Coated Lag ScrewSmith & Nephew, Inc. · 2005
Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Descendant · 4 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 5 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2005high 12 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 49 · See all

K050849HA Coated Lag ScrewSmith & Nephew, Inc. · 2005 · cites it directly34descendants
K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K953397	Hex-Fix Field Fixator	Smith & Nephew Richards, Inc.	1995	—
−2	K023134	Jet-X Tin Coated Half Pins	Smith & Nephew, Inc.	2002	—
−1	K023921	Jet-X HA Coated Half Pins	Smith & Nephew, Inc.	2003	27
0 (this device)	K033289	Modification to Jet-X HA Coated Half Pins	Smith & Nephew, Inc.	2004	—
+1	K050849	HA Coated Lag Screw	Smith & Nephew, Inc.	2005	—
+2	K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	2013	—
+3	K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2
+4	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+5	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2012	1	0
2013	1	0
2014	2	0
2017	3	0
2018	3	0
2020	3	0
2021	3	0
2022	4	0
2023	3	0
2024	8	0
2025	12	0
2026	5	0

FIG. 1 — Lineage of K033289, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K023921	Jet-X HA Coated Half Pins Summary page 1 …ct Code and Panel Code: JDW/Orthopedics/87 Device Description: The Jet-X Half Pin is a modification of the Jet-X Half Pin that was cleared for market under K023921. This submission describes measures taken to implement an alternate supplier for application of the hydroxyapatite (HA) coating.…	Smith & Nephew, Inc.	2003	27

Also cleared against K023921: 5 other devices →

What descends from it? (49)

See all 49

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050849	HA Coated Lag Screw	Smith & Nephew, Inc.	2005	34
K120871	Smith & Nephew, Inc. External Fixation System Instrumentation	Smith & Nephew, Inc.	2012	6
K132820	Vilex Ultima External Fixation System with HA Coated Pins and Wires	Vilex, Inc.	2014	5
K210784	Extended HA Half Pins	Smith & Nephew, Inc.	2021	0

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?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 11 months on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K050849 (Smith & Nephew, Inc., 2005) has gone furthest, with 34 descendants of its own.
5 other devices also cite its predicate K023921.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033289 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033289: Modification to Jet-X HA Coated Half Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033289

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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