510(k) Report

510(k) · Cleared

Cleared

Dorsal Intramedullary Plate

K042437510(k) TraditionalCleared Oct 8, 200430-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

Deo Volente Orthopaedics, LLC · HRS Plate, Fixation, Bone

Cleared on Oct 8, 2004 as substantially equivalent to K032705 (Hand Innovations, Inc., 2003) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.

Decided
Oct 8, 2004
Review
30 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K962616 (1996). 8 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1996: 1 other ancestor2008: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2016: 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. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants K032705 · 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
  1. Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 1 generation backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. This deviceK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
  7. Descendant · cites it directly · 6 of its ownK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
  8. Descendant · 2 generations on · 4 of its ownK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
  9. Descendant · 3 generations on · 2 of its ownK131552 Conventus DRSConventus Orthopaedics · 2014
  10. Descendant · 3 generations on · 1 of its ownK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
  11. Descendant · 3 generations on · 0 of its ownK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12013: 12014: 12015: 22016: 1
2008high 2 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008 · cites it directly6descendants
  • K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013 · 2 generations on4descendants
  • K131552Conventus DRSConventus Orthopaedics · 2014 · 3 generations on2descendants
  • K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015 · 3 generations on1descendant
  • K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−4K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−3K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−2K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−1K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
0 (this device)K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC2004—
+1K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.2008—
+2K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics2013—
+3K131552Conventus DRSConventus Orthopaedics2014—
+3K151379Conventus PRS SystemConventus Orthopaedics, Inc.2015—
+3K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201310
201410
201520
201610
FIG. 1 — Lineage of K042437, 1996–2016Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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
*K032705Distal Radius Fracture Repair System
Summary page 1
…d accessories. DEVICE PRODUCT CODE: 87 HRS PREDICATE DEVICES: Hand Innovations, Distal Radius Fracture Repair System, K032705, cleared 1 Oct 2003 · Wright Medical Technology, Locon-T Distal Radial Plate System, K994061, cleared 30 Nov 1999 D…
Hand Innovations, Inc.2003—
*K994061Locon-T Distal Radial Plate
Summary page 1
…CES: Hand Innovations, Distal Radius Fracture Repair System, K032705, cleared 1 Oct 2003 · Wright Medical Technology, Locon-T Distal Radial Plate System, K994061, cleared 30 Nov 1999 DEVICE DESCRIPTION: This anatomically contoured plate system offers se…
Wrightmedicaltechnologyinc2000—

Also cleared against K032705: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086

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 8 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K071809 (Sonoma Orthopedic Products, Inc., 2008) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K032705.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The fixation of fractures and osteotomies involving the distal radius.

This single use device is for cementless use only.

Indications for use as stated in the FDA summary.

Also cleared against K032705

1 other device cites the same predicate.

  • K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 20051 recall

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K042437 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042437: Dorsal Intramedullary Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042437

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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