510(k) Report

510(k) · Cleared

Cleared

Synthes LCP Distal Tibia Plates

K013248510(k) TraditionalCleared Dec 19, 200182-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Dec 19, 2001 after an 82-day review. The FDA summary names no predicate by number. 116 later devices descend from it.

Decided
Dec 19, 2001
Review
82 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

116 later devices descend from it, 20 citing it directly.

Descendants, by year cleared 2014: 5 descendants cleared2022: 6 descendants cleared2023: 17 descendants cleared2016: 4 descendants cleared2017: 9 descendants cleared2004: 1 descendant cleared2012: 1 descendant cleared2020: 10 descendants cleared2009: 2 descendants cleared2018: 5 descendants cleared2024: 18 descendants cleared2007: 1 descendant cleared2019: 5 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2013: 1 descendant cleared2026: 12 descendants cleared2025: 9 descendants cleared2015: 1 descendant cleared2021: 4 descendants cleared2011: 2 descendants cleared200020052010201520202025
  1. This deviceK013248 Synthes LCP Distal Tibia PlatesSynthes (Usa) · 2001
  2. Descendant · cites it directly · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
  3. Descendant · cites it directly · 26 of its ownK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
  4. Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
  5. Descendant · cites it directly · 25 of its ownK063672 Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2007 · Recalled
  6. Descendant · 3 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12007: 12009: 22010: 22011: 22012: 12013: 12014: 52015: 12016: 42017: 92018: 52019: 52020: 102021: 42022: 62023: 172024: 182025: 92026: 12
2004high 18 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 116 · See all
  • K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · cites it directly55descendants
  • K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014 · cites it directly26descendants
  • K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants
  • K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2007 · cites it directly25descendants
  • K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013248Synthes LCP Distal Tibia PlatesSynthes (Usa)2001—
+1K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)2010—
+1K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG2014—
+2K153379AxSOS 3TiStryker GmbH2016—
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH20071
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200710
200920
201020
201120
201210
201310
201450
201510
201640
201790
201850
201950
2020100
202140
202260
2023170
2024180
202590
2026120
FIG. 1 — Lineage of K013248, 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?

The FDA summary names no predicate by number.

What descends from it? (116)

See all 116

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

NumberDeviceApplicantDecidedDescendants
K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055
K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426
K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200725
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
K090666PediplatesOrthoPediatrics Corp.200915
K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011
K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811
K042237Ebi Periarticular Plating SystemEbi, L.P.20043
K213059Tibia and Fibula SystemAuxein Medical Private Limited20232
K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172

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, K092812 (Synthes (Usa), 2010) has gone furthest, with 55 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 Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the Synthes Small Fragment LCP System.

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/K013248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013248: Synthes LCP Distal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013248

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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