510(k) Report

510(k) · Cleared

Cleared

Synthes LCP Distal Femur Plates

K062564510(k) TraditionalCleared Oct 19, 200649-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 Oct 19, 2006 after a 49-day review. The FDA summary names its predicate without a number. 150 later devices descend from it.

Decided
Oct 19, 2006
Review
49 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

150 later devices descend from it, 25 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2022: 12 descendants cleared2011: 4 descendants cleared2023: 10 descendants cleared2025: 15 descendants cleared2016: 5 descendants cleared2021: 10 descendants cleared2020: 11 descendants cleared2009: 1 descendant cleared2018: 9 descendants cleared2019: 8 descendants cleared2015: 9 descendants cleared2017: 10 descendants cleared2013: 3 descendants cleared2012: 4 descendants cleared2026: 17 descendants cleared2010: 2 descendants cleared2024: 17 descendants cleared20052010201520202025
  1. This deviceK062564 Synthes LCP Distal Femur PlatesSynthes (Usa) · 2006
  2. Descendant · cites it directly · 62 of its ownK110354 4.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · Recalled
  3. Descendant · cites it directly · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  4. Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  5. Descendant · 2 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  6. Descendant · 3 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 42012: 42013: 32014: 32015: 92016: 52017: 102018: 92019: 82020: 112021: 102022: 122023: 102024: 172025: 152026: 17
2009high 17 (2024) · low 1 (2009)2026

Most influential descendants

Showing 5 of 150 · See all
  • K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · cites it directly62descendants
  • K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · cites it directly60descendants
  • K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 2 generations on28descendants
  • K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 3 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062564Synthes LCP Distal Femur PlatesSynthes (Usa)2006—
+1K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA20112
+1K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.20095
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
+2K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC2012—
+3K143385Acumed Ankle Plating SystemAcumed, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201140
201240
201330
201430
201590
201650
2017100
201890
201980
2020110
2021100
2022120
2023100
2024170
2025150
2026170
FIG. 1 — Lineage of K062564, 2006–2026Source: 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 LCP Curved Condylar Plates
Named without a submission number
—

What descends from it? (150)

See all 150

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

NumberDeviceApplicantDecidedDescendants
K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA201162
K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.200960
K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG201319
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615
K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811
K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154
K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K121494Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5…Aap Implantate AG20122
K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221

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, K110354 (Synthes USA, 2011) has gone furthest, with 62 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?

Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and 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 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/K062564 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062564: Synthes LCP Distal Femur Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062564

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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