510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates

K070946510(k) TraditionalCleared Jun 6, 200763-day reviewClass II21 CFR 888.3030Recalls 1

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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Jun 6, 2007 after a 63-day review. The FDA summary names its predicate without a number. 132 later devices descend from it. It has been recalled once.

Decided
Jun 6, 2007
Review
63 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
0

132 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2018: 8 descendants cleared2016: 3 descendants cleared2015: 4 descendants cleared2017: 12 descendants cleared2010: 1 descendant cleared2013: 7 descendants cleared2011: 1 descendant cleared2014: 5 descendants cleared2023: 10 descendants cleared2022: 10 descendants cleared2020: 6 descendants cleared2024: 21 descendants cleared2019: 6 descendants cleared2026: 16 descendants cleared2021: 6 descendants cleared2025: 15 descendants cleared2012: 1 descendant cleared20052010201520202025
  1. This deviceK070946 Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius…Synthes (Usa) · 2007
  2. Descendant · cites it directly · 80 of its ownK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
  3. Descendant · cites it directly · 59 of its ownK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
  4. Descendant · 2 generations on · 56 of its ownK112455 Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011
  5. Descendant · 3 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
  6. Descendant · 2 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013

Showing 5 of 132 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12013: 72014: 52015: 42016: 32017: 122018: 82019: 62020: 62021: 62022: 102023: 102024: 212025: 152026: 16
2010high 21 (2024) · low 1 (2010)2026

Most influential descendants

Showing 5 of 132 · See all
  • K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010 · cites it directly80descendants
  • K142906APTUS Wrist 2.5 SystemMedartis AG · 2015 · cites it directly59descendants
  • K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011 · 2 generations on56descendants
  • K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 3 generations on40descendants
  • K132502Variax 2 SystemStryker Trauma AG · 2013 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070946Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSynthes (Usa)2007—
+1K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.2010—
+1K142906APTUS Wrist 2.5 SystemMedartis AG2015—
+2K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics2011—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012—
+2K132502Variax 2 SystemStryker Trauma AG2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201370
201450
201540
201630
2017120
201880
201960
202060
202160
2022100
2023100
2024210
2025150
2026160
FIG. 1 — Lineage of K070946, 2007–2026Source: 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 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
*—Synthes Locking Distal Radius Plating System
Named without a submission number
—
*—Synthes Small Fragment Dynamic Compression Locking System
Named without a submission number
—

What descends from it? (132)

See all 132

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

NumberDeviceApplicantDecidedDescendants
K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080
K142906APTUS Wrist 2.5 SystemMedartis AG201559
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC20186
K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 2, 2016Class IIZ-1949-2016Under Investigation by firmProduct incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K100271 (Howmedica Osteonics Corp., 2010) has gone furthest, with 80 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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?

Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for

fractures, osteotomies, and non-unions of the radius and other small

bones.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K070946 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070946

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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