510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Synthes (Usa) LCP Curved Plates

K041911510(k) TraditionalCleared Sep 8, 200455-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) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Sep 8, 2004 after a 55-day review. The FDA summary names its predicate without a number. 237 later devices descend from it. It has been recalled once.

Decided
Sep 8, 2004
Review
55 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
0

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

Descendants, by year cleared 2014: 9 descendants cleared2011: 5 descendants cleared2025: 22 descendants cleared2018: 13 descendants cleared2017: 19 descendants cleared2008: 1 descendant cleared2023: 19 descendants cleared2013: 13 descendants cleared2016: 9 descendants cleared2024: 26 descendants cleared2012: 6 descendants cleared2020: 13 descendants cleared2019: 14 descendants cleared2010: 2 descendants cleared2015: 13 descendants cleared2026: 24 descendants cleared2022: 14 descendants cleared2009: 1 descendant cleared2021: 14 descendants cleared200020052010201520202025
  1. This deviceK041911 Synthes (Usa) LCP Curved PlatesSynthes (Usa) · 2004
  2. Descendant · cites it directly · 186 of its ownK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  3. Descendant · cites it directly · 62 of its ownK110354 4.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · Recalled
  4. Descendant · 2 generations on · 51 of its ownK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
  5. Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  6. Descendant · 2 generations on · 27 of its ownK130009 Variax 2 Compression Plating SystemStryker Trauma AG · 2013 · Recalled

Showing 5 of 237 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22011: 52012: 62013: 132014: 92015: 132016: 92017: 192018: 132019: 142020: 132021: 142022: 142023: 192024: 262025: 222026: 24
2008high 26 (2024) · low 1 (2008)2026

Most influential descendants

Showing 5 of 237 · See all
  • K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa) · 2008 · cites it directly186descendants
  • K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · cites it directly62descendants
  • K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa) · 2009 · 2 generations on51descendants
  • K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
  • K130009Variax 2 Compression Plating SystemStryker Trauma AG · 2013 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041911Synthes (Usa) LCP Curved PlatesSynthes (Usa)2004—
+1K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
+1K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA20112
+2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates…Synthes (Usa)2009—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
+2K130009Variax 2 Compression Plating SystemStryker Trauma AG20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201150
201260
2013130
201490
2015130
201690
2017190
2018130
2019140
2020130
2021140
2022140
2023190
2024260
2025220
2026240
FIG. 1 — Lineage of K041911, 2004–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 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 Large Fragment Dynamic Compression System
Named without a submission number
—
*—Synthes Locking Condylar Plating System
Named without a submission number
—

What descends from it? (237)

See all 237

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

NumberDeviceApplicantDecidedDescendants
K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa)2008186
K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA201162
K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184
K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141
K242988Genostis Osteosynthesis SystemGenostis AF20250
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC20110

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 30, 2013Class IIZ-0409-2014Process controlThe Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082807 (Synthes (Usa), 2008) has gone furthest, with 186 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions.

The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.

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 KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K041911 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041911: Synthes (Usa) LCP Curved Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041911

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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