510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate

K010766510(k) TraditionalCleared Jun 12, 200190-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) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jun 12, 2001 after a 90-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.

Decided
Jun 12, 2001
Review
90 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 4 descendants cleared2025: 4 descendants cleared2013: 1 descendant cleared2004: 1 descendant cleared2018: 2 descendants cleared2017: 1 descendant cleared2009: 1 descendant cleared2023: 3 descendants cleared2015: 2 descendants cleared2022: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2019: 1 descendant cleared200020052010201520202025
  1. This deviceK010766 Synthes (Usa) Large Fragment Locking Compression Plate (LCP)…Synthes (Usa) · 2001
  2. Descendant · cites it directly · 9 of its ownK130108 Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013
  3. Descendant · cites it directly · 4 of its ownK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
  4. Descendant · cites it directly · 3 of its ownK042237 Ebi Periarticular Plating SystemEbi, L.P. · 2004 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK092078 Optilock Periarticular PlatingBiomet Trauma · 2009
  6. Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2004: 12009: 12013: 12014: 42015: 22017: 12018: 22019: 12022: 12023: 32024: 22025: 42026: 1
2004high 4 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 24 · See all
  • K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013 · cites it directly9descendants
  • K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly4descendants
  • K042237Ebi Periarticular Plating SystemEbi, L.P. · 2004 · cites it directly3descendants
  • K092078Optilock Periarticular PlatingBiomet Trauma · 2009 · 2 generations on2descendants
  • K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010766Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T PlateSynthes (Usa)2001—
+1K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.2013—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018—
+1K042237Ebi Periarticular Plating SystemEbi, L.P.200410
+2K092078Optilock Periarticular PlatingBiomet Trauma2009—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201310
201440
201520
201710
201820
201910
202210
202330
202420
202540
202610
FIG. 1 — Lineage of K010766, 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 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 21.4 · 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? (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 T Plates
Named without a submission number
—

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139
K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184
K042237Ebi Periarticular Plating SystemEbi, L.P.20043
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
K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140

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, K130108 (Xiamen Double Engine Medical Material Co., Ltd., 2013) has gone furthest, with 9 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?

Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

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/K010766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010766

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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