510(k) Report

510(k) · Cleared

Cleared

Hex-Fix Field Fixator

K953397510(k) TraditionalCleared Oct 31, 1995103-day reviewClass II21 CFR 888.3030

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

Smith & Nephew Richards, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Oct 31, 1995 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Oct 31, 1995
Review
103 days
Class
Class II
Product code
LXT
Recalls
None
Predicates
0

57 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant cleared2020: 4 descendants cleared2002: 1 descendant cleared1997: 1 descendant cleared2003: 1 descendant cleared2025: 13 descendants cleared2026: 6 descendants cleared2024: 8 descendants cleared2021: 3 descendants cleared2004: 1 descendant cleared2014: 2 descendants cleared2005: 1 descendant cleared2013: 1 descendant cleared2017: 3 descendants cleared2022: 4 descendants cleared2018: 3 descendants cleared2023: 3 descendants cleared1995200020052010201520202025
  1. This deviceK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
  2. Descendant · cites it directly · 51 of its ownK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
  3. Descendant · 2 generations on · 50 of its ownK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 49 of its ownK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
  5. Descendant · 3 generations on · 34 of its ownK050849 HA Coated Lag ScrewSmith & Nephew, Inc. · 2005
  6. Descendant · 4 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12003: 12004: 12005: 12009: 12012: 12013: 12014: 22017: 32018: 32020: 42021: 32022: 42023: 32024: 82025: 132026: 6
1997high 13 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 57 · See all
  • K023134Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002 · cites it directly51descendants
  • K023921Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · 2 generations on50descendants
  • K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004 · 3 generations on49descendants
  • K050849HA Coated Lag ScrewSmith & Nephew, Inc. · 2005 · 3 generations on34descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 4 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
200410
200510
200910
201210
201310
201420
201730
201830
202040
202130
202240
202330
202480
2025130
202660
FIG. 1 — Lineage of K953397, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Planning a device in LXT? 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 LXT device

  1. #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K023134Jet-X Tin Coated Half PinsSmith & Nephew, Inc.200251
K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.199711
K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910
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?

  • Of its descendants, K023134 (Smith & Nephew, Inc., 2002) has gone furthest, with 51 descendants of its own.

How does its category compare?

All LXT devices

LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXT

1in 2023

2007: 12008: 12009: 12011: 12013: 22023: 1
2007high 2 (2013) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXT

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

Recalls per year · LXT

2in 2018

2007: 12009: 72018: 2
2007high 7 (2009) · low 0 (2008)2026

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

Adverse event reports per year · LXT

7in 2025

2007: 262008: 582009: 412010: 332011: 852012: 422013: 392014: 362015: 352016: 382017: 662018: 732019: 402020: 322021: 242022: 212023: 182024: 272025: 7
2007high 85 (2011) · low 7 (2025)2025

MAUDE reports naming product code LXT, 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
20071—126
20081—058
20091—741
20100—033
20111—085
20120—042
20132—039
20140—036
20150—035
20160—038
20170—066
20180—273
20190—040
20200—032
20210—024
20220—021
20231—018
20240—027
20250—07
20260—0—

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

Recent decisions in LXT

The LXT category page

  • K230067Para-Fix External Fixation SystemNew Paradigm Biomedical · 2023
  • K131636Polarus ConnectAcumed, LLC · 2013
  • K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowBiomet · 20131 recall
  • K112345Distal Volar Radius Plating SystemsMedos International SARL · 20114 recalls
  • K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth…DePuy Orthopaedics, Inc. · 2009

https://510kreport.com/device/K953397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953397: Hex-Fix Field Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953397

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026