510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Synthes (Usa) Tibial Nail System EX

K040762510(k) TraditionalCleared Apr 12, 200418-day reviewClass II21 CFR 888.3030Recalls 2

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

Synthes (Usa) · JDS Nail, Fixation, Bone

Cleared on Apr 12, 2004 after an 18-day review. The FDA summary names its predicate without a number. 48 later devices descend from it. It has been recalled 2 times.

Decided
Apr 12, 2004
Review
18 days
Class
Class II
Product code
JDS
Recalls
2
Predicates
0

48 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2020: 6 descendants cleared2008: 1 descendant cleared2017: 4 descendants cleared2019: 3 descendants cleared2014: 4 descendants cleared2011: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2026: 8 descendants cleared2022: 5 descendants cleared2021: 2 descendants cleared2024: 3 descendants cleared2025: 6 descendants cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK040762 Synthes (Usa) Tibial Nail System EXSynthes (Usa) · 2004
  2. Descendant · cites it directly · 18 of its ownK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
  3. Descendant · 2 generations on · 17 of its ownK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
  4. Descendant · cites it directly · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
  5. Descendant · 2 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
  6. Descendant · 3 generations on · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 12014: 42015: 12017: 42018: 12019: 32020: 62021: 22022: 52023: 22024: 32025: 62026: 8
2008high 8 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 48 · See all
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · cites it directly18descendants
  • K131365T2 Tibial Nailing SystemStryker Trauma AG · 2013 · 2 generations on17descendants
  • K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · cites it directly16descendants
  • K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 2 generations on15descendants
  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040762Synthes (Usa) Tibial Nail System EXSynthes (Usa)2004—
+1K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)20111
+2K131365T2 Tibial Nailing SystemStryker Trauma AG20134
+1K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker Trauma GmbH2018—
+2K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System…Stryker Trauma GmbH2019—
+3K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail…Stryker GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201310
201440
201510
201740
201810
201930
202060
202120
202250
202320
202430
202560
202680
FIG. 1 — Lineage of K040762, 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 JDS? 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 JDS device

  1. #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 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 Titanium Solid and Cannulated Tibial Nail
Named without a submission number
—

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)201118
K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816
K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811
K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204
K192003Auxein Nailing SystemAuxein Medical Private Limited20202
K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172
K143245GPC Intramedullary Nailing SystemsGpc Medical Limited20152
K131609Double Engine Intrameddullary Nail SystemXiamen Double Engine Medical Material Co., Ltd.20141
K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…Synthes (USA) Products, LLC20200
K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 3, 2015Class IIZ-2051-2015Employee errorA specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
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, K111667 (Synthes (Usa), 2011) has gone furthest, with 18 descendants of its own.

How does its category compare?

All JDS devices

JDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDS

1in 2025

2007: 22008: 12011: 12013: 12015: 12020: 32023: 12024: 32025: 1
2007high 3 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDS

146in 2024

2020: 106 days median2024: 146 days median
2007high 146 (2024) · low 106 (2020)2026

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

Recalls per year · JDS

2in 2025

2009: 32010: 22013: 42017: 12020: 12025: 2
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JDS

497in 2025

2007: 1612008: 1692009: 1602010: 702011: 1042012: 1952013: 2842014: 3882015: 3162016: 5062017: 2872018: 3202019: 4902020: 6432021: 6302022: 5892023: 3572024: 4662025: 497
2007high 643 (2020) · low 70 (2010)2025

MAUDE reports naming product code JDS, 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
20072—0161
20081—0169
20090—3160
20100—270
20111—0104
20120—0195
20131—4284
20140—0388
20151—0316
20160—0506
20170—1287
20180—0320
20190—0490
202031061643
20210—0630
20220—0589
20231—0357
202431460466
20251—2497
20260—0—

What is it indicated for?

Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

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 JDS

The JDS category page

  • K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
  • K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. · 2024
  • K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. · 2024
  • K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023

https://510kreport.com/device/K040762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040762: Synthes (Usa) Tibial Nail System EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040762

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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