510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) LCP Proximal Femur Plate and Screws

K030858510(k) TraditionalCleared Apr 4, 200317-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 Apr 4, 2003 after a 17-day review. The FDA summary names its predicate without a number. 106 later devices descend from it.

Decided
Apr 4, 2003
Review
17 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

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

Descendants, by year cleared 2016: 6 descendants cleared2007: 1 descendant cleared2015: 5 descendants cleared2017: 8 descendants cleared2019: 3 descendants cleared2010: 1 descendant cleared2020: 5 descendants cleared2018: 7 descendants cleared2022: 6 descendants cleared2008: 1 descendant cleared2009: 2 descendants cleared2011: 1 descendant cleared2021: 5 descendants cleared2013: 1 descendant cleared2024: 15 descendants cleared2014: 7 descendants cleared2025: 11 descendants cleared2023: 13 descendants cleared2026: 8 descendants cleared200020052010201520202025
  1. This deviceK030858 Synthes (Usa) LCP Proximal Femur Plate and ScrewsSynthes (Usa) · 2003
  2. Descendant · cites it directly · 93 of its ownK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
  3. Descendant · 2 generations on · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  4. Descendant · 3 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  5. Descendant · 2 generations on · 38 of its ownK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
  6. Descendant · 2 generations on · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 22010: 12011: 12013: 12014: 72015: 52016: 62017: 82018: 72019: 32020: 52021: 52022: 62023: 132024: 152025: 112026: 8
2007high 15 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 106 · See all
  • K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc. · 2007 · cites it directly93descendants
  • K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · 2 generations on77descendants
  • K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on46descendants
  • K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010 · 2 generations on38descendants
  • K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · 2 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030858Synthes (Usa) LCP Proximal Femur Plate and ScrewsSynthes (Usa)2003—
+1K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.2007—
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.2010—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200920
201010
201110
201310
201470
201550
201660
201780
201870
201930
202050
202150
202260
2023130
2024150
2025110
202680
FIG. 1 — Lineage of K030858, 2003–2026Source: 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 4.5mm Broad Locking Compression Plate (LCP)
Named without a submission number
—

What descends from it? (106)

See all 106

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

NumberDeviceApplicantDecidedDescendants
K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161
K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151
K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151
K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190

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, K072818 (Smith & Nephew, Inc., 2007) has gone furthest, with 93 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 Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal 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/K030858 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030858

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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