510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synthes Locking Distal Radius Plating System

K012114510(k) TraditionalCleared Sep 28, 200184-day reviewClass II21 CFR 888.3030Recalls 3

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 Sep 28, 2001 after an 84-day review. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate. 205 later devices descend from it. It has been recalled 3 times.

Decided
Sep 28, 2001
Review
84 days
Class
Class II
Product code
HRS
Recalls
3
Predicates
0

205 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2014: 14 descendants cleared2023: 11 descendants cleared2025: 16 descendants cleared2016: 9 descendants cleared2013: 12 descendants cleared2004: 3 descendants cleared2020: 11 descendants cleared2015: 7 descendants cleared2010: 4 descendants cleared2019: 11 descendants cleared2017: 17 descendants cleared2006: 2 descendants cleared2022: 13 descendants cleared2008: 2 descendants cleared2011: 5 descendants cleared2005: 3 descendants cleared2012: 3 descendants cleared2007: 3 descendants cleared2024: 18 descendants cleared2018: 12 descendants cleared2026: 19 descendants cleared2021: 10 descendants cleared200020052010201520202025
  1. This deviceK012114 Synthes Locking Distal Radius Plating SystemSynthes (Usa) · 2001
  2. Descendant · cites it directly · 162 of its ownK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 80 of its ownK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
  4. Descendant · 3 generations on · 56 of its ownK112455 Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011
  5. Descendant · cites it directly · 50 of its ownK102694 2.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · Recalled
  6. Descendant · 4 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012

Showing 5 of 205 descendants. See all descendants

Descendants cleared per year

2004: 32005: 32006: 22007: 32008: 22010: 42011: 52012: 32013: 122014: 142015: 72016: 92017: 172018: 122019: 112020: 112021: 102022: 132023: 112024: 182025: 162026: 19
2004high 19 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 205 · See all
  • K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · cites it directly162descendants
  • K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010 · 2 generations on80descendants
  • K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011 · 3 generations on56descendants
  • K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · cites it directly50descendants
  • K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 4 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012114Synthes Locking Distal Radius Plating SystemSynthes (Usa)2001—
+1K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc.20042
+2K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.2010—
+3K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics2011—
+1K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)20103
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200530
200620
200730
200820
201040
201150
201230
2013120
2014140
201570
201690
2017170
2018120
2019110
2020110
2021100
2022130
2023110
2024180
2025160
2026190
FIG. 1 — Lineage of K012114, 2001–2026Source: 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? (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
*—Synthes Distal Radius Plate System
Named without a submission number
—

What descends from it? (205)

See all 205

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

NumberDeviceApplicantDecidedDescendants
K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc.2004162
K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)201050
K123875Aap Radius Set 2.5Aap Implantate AG201321
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615
K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148
K061917Distal Radius Locking Plating SystemNewclip Technics20066
K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191
K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 28, 2016Class IIZ-2389-2016Nonconforming Material/ComponentIt was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature…
Nov 2, 2015Class IIZ-0323-2016Process controlIt was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment…
Dec 5, 2006Not classifiedZ-0489-2007OtherHole is malformed, leading to reduced construct strength.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040593 (Zimmer, Inc., 2004) has gone furthest, with 162 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.

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 Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K012114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012114: Synthes Locking Distal Radius Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012114

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026