510(k) Report

510(k) · Cleared

Cleared

Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model (S

K090374510(k) SpecialCleared Mar 11, 200922-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

DePuy Orthopaedics, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Mar 11, 2009 as substantially equivalent to K050932 (Hand Innovations, Inc., 2005) after a 22-day review. Its family tree reaches back 6 generations to 1996. 18 later devices descend from it.

Decided
Mar 11, 2009
Review
22 days
Class
Class II
Product code
LXT
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K962616 (1996). 8 ancestors in all. 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1996: 1 other ancestor2011: 1 descendant cleared2012: 2 descendants cleared2016: 3 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 5 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 9 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50+5
  1. Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 2 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 1 generation backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. This deviceK090374 Sterile DVR Anatomic Plates Various Configurations) Model (S)…DePuy Orthopaedics, Inc. · 2009
  8. Descendant · cites it directly · 15 of its ownK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  9. Descendant · 2 generations on · 11 of its ownK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
  10. Descendant · 2 generations on · 10 of its ownK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
  11. Descendant · 2 generations on · 4 of its ownK160002 Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016
  12. Descendant · 2 generations on · 4 of its ownK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22013: 22015: 22016: 32017: 22018: 12019: 12020: 12022: 12025: 12026: 1
2011high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 18 · See all
  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly15descendants
  • K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012 · 2 generations on11descendants
  • K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on10descendants
  • K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016 · 2 generations on4descendants
  • K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−5K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−4K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−3K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−2K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−1K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
0 (this device)K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2…DePuy Orthopaedics, Inc.2009—
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.2011—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.2012—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.2013—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.2016—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201320
201520
201630
201720
201810
201910
202010
202210
202510
202610
FIG. 1 — Lineage of K090374, 1996–2026Source: 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), 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K050932Distal Volar Radius Anatomical Plate System
Summary page 1
…Fixation, Bone Name of The device is substantially equivalent to the currently marketed DePuy Predicate DVR Anatomic Plating System, K050932. Devices Classification Class II, 21 CFR 888.3030 Performance Performance standards have not been es…
Hand Innovations, Inc.20051

Also cleared against K050932: 5 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121

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 13 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K102597 (N.M.B. Medical Applications, Ltd., 2011) has gone furthest, with 15 descendants of its own.
  • 5 other devices also cite its predicate K050932.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The DePuy Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.

Indications for use as stated in the FDA summary.

Also cleared against K050932

5 other devices cite the same predicate.

  • K191972ARIX Wrist SystemJeil Medical Corporation · 2019
  • K133939Modified Distal Radius Plating SystemBiomet · 20142 recalls
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls
  • K060864Multidirectional Threaded PegHand Innovations, LLC · 2006
  • K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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
  • K073135Synthes (Usa) Hybrid External Fixator ModificationsSynthes (Usa) · 2008

https://510kreport.com/device/K090374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090374: Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model (S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090374

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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