510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Synthes (Usa) Lateral Entry Femoral Nail System

K040336510(k) TraditionalCleared Apr 12, 200461-day reviewClass II21 CFR 888.3020Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Apr 12, 2004 after a 61-day review. The FDA summary names its predicate without a number. 74 later devices descend from it. It has been recalled 2 times.

Decided
Apr 12, 2004
Review
61 days
Class
Class II
Product code
HSB
Recalls
2
Predicates
0

74 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2024: 5 descendants cleared2020: 5 descendants cleared2022: 7 descendants cleared2005: 1 descendant cleared2018: 9 descendants cleared2017: 5 descendants cleared2009: 4 descendants cleared2008: 2 descendants cleared2014: 3 descendants cleared2026: 10 descendants cleared2021: 2 descendants cleared2013: 1 descendant cleared2025: 8 descendants cleared2019: 5 descendants cleared2012: 1 descendant cleared2023: 5 descendants cleared200020052010201520202025
  1. This deviceK040336 Synthes (Usa) Lateral Entry Femoral Nail SystemSynthes (Usa) · 2004
  2. Descendant · cites it directly · 53 of its ownK043270 Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631…Zimmer GmbH · 2005 · Recalled
  3. Descendant · 2 generations on · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
  6. Descendant · 3 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22009: 42011: 12012: 12013: 12014: 32017: 52018: 92019: 52020: 52021: 22022: 72023: 52024: 52025: 82026: 10
2005high 10 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 74 · See all
  • K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH · 2005 · cites it directly53descendants
  • K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · 2 generations on39descendants
  • K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · 2 generations on35descendants
  • K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 3 generations on17descendants
  • K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 3 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040336Synthes (Usa) Lateral Entry Femoral Nail SystemSynthes (Usa)2004—
+1K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651…Zimmer GmbH20052
+2K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…Zimmer, Inc.200916
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.200815
+3K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…Stryker Trauma GmbH2018—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker Trauma GmbH2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
200940
201110
201210
201310
201430
201750
201890
201950
202050
202120
202270
202350
202450
202580
2026100
FIG. 1 — Lineage of K040336, 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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? (3)

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 Ti Cannulated Femoral Nail
Named without a submission number
—
*—Smith & Nephew TriGen Antegrade Femoral Nail
Named without a submission number
—
*—DePuy ACE ART Femoral Nail
Named without a submission number
—

What descends from it? (74)

See all 74

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

NumberDeviceApplicantDecidedDescendants
K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH200553
K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.20096
K192003Auxein Nailing SystemAuxein Medical Private Limited20202
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182
K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC20172
K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd.20240
K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220
K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC20110

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

Recalls of this device

DateClassRecallRoot causeReason
May 27, 2015Class IIZ-1915-2015Process controlcertain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and…
Nov 2, 2012Class IIZ-2058-2013Packaging change controlRecall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K043270 (Zimmer GmbH, 2005) has gone furthest, with 53 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, 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 HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K040336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040336: Synthes (Usa) Lateral Entry Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040336

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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