510(k) Report

510(k) · Cleared

Cleared

Jet-X Tin Coated Half Pins

K023134510(k) SpecialCleared Oct 9, 200219-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 Oct 9, 2002 as substantially equivalent to K953397 (Smith & Nephew Richards, Inc., 1995) after a 19-day review. Its family tree reaches back 1 generation to 1995. 51 later devices descend from it.

Decided
Oct 9, 2002
Review
19 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K953397 (1995). 51 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2020: 3 descendants cleared2003: 1 descendant cleared2021: 3 descendants cleared2004: 1 descendant cleared2014: 2 descendants cleared2005: 1 descendant cleared2025: 12 descendants cleared2026: 5 descendants cleared2024: 8 descendants cleared2013: 1 descendant cleared2017: 3 descendants cleared2022: 4 descendants cleared2018: 3 descendants cleared2023: 3 descendants clearedK953397 · Hex-Fix Field Fixator · Smith & Nephew Richards, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 15 descendants6 generations forward: 10 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 2 descendants K953397 · Hex-Fix Field Fixator · Smith & Nephew Richards, Inc. · 19950+5
  1. Root · 1 generation backK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
  2. This deviceK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
  3. Descendant · cites it directly · 50 of its ownK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 49 of its ownK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
  5. Descendant · 2 generations on · 34 of its ownK050849 HA Coated Lag ScrewSmith & Nephew, Inc. · 2005
  6. Descendant · 3 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  7. Descendant · 4 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12012: 12013: 12014: 22017: 32018: 32020: 32021: 32022: 42023: 32024: 82025: 122026: 5
2003high 12 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 51 · See all
  • K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · cites it directly50descendants
  • K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004 · 2 generations on49descendants
  • K050849HA Coated Lag ScrewSmith & Nephew, Inc. · 2005 · 2 generations on34descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 3 generations on33descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 4 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953397Hex-Fix Field FixatorSmith & Nephew Richards, Inc.1995—
0 (this device)K023134Jet-X Tin Coated Half PinsSmith & Nephew, Inc.2002—
+1K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc.200327
+2K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc.2004—
+2K050849HA Coated Lag ScrewSmith & Nephew, Inc.2005—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
201210
201310
201420
201730
201830
202030
202130
202240
202330
202480
2025120
202650
FIG. 1 — Lineage of K023134, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K953397Hex-Fix Field FixatorSmith & Nephew Richards, Inc.1995—
*—Richards Titanium Half Pin
Named without a submission number
—

Also cleared against K953397: 4 other devices →

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc.200350
K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126
K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205

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?

  • Its one ancestor has no recall.
  • Of its descendants, K023921 (Smith & Nephew, Inc., 2003) has gone furthest, with 50 descendants of its own.
  • 4 other devices also cite its predicate K953397.

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

2007: 22009: 12010: 22011: 12012: 12013: 22014: 22015: 12017: 12018: 12019: 12020: 22021: 22022: 22025: 22026 (partial year): 1
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

2009: 22010: 22012: 522017: 22018: 21
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

2007: 252008: 262009: 292010: 292011: 552012: 752013: 692014: 272015: 702016: 462017: 432018: 942019: 5752020: 4022021: 1682022: 1212023: 722024: 652025: 29
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—025
20080—026
20091—229
20102—229
20111—055
20121—5275
20132—069
20142—027
20151—070
20160—046
20171—243
20181—2194
20191—0575
20202—0402
20212—0168
20222—0121
20230—072
20240—065
20252—029
20261—0—

What is it indicated for?

The Jet-X TIN 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.

Also cleared against K953397

4 other devices cite the same predicate.

  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other…Smith & Nephew · 2020
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  • K090926Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
  • K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div. · 1997

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in JDW

The JDW category page

  • K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
  • K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC · 2025
  • K241357XT3 SystemBiodynamik, Inc. · 2025
  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022

https://510kreport.com/device/K023134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023134: Jet-X Tin Coated Half Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023134

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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