510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Trigen Intertan

K040212510(k) SpecialCleared Feb 20, 200421-day reviewClass II21 CFR 888.3030Recalls 6

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

Smith & Nephew, Inc. · JDS Nail, Fixation, Bone

Cleared on Feb 20, 2004 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 4 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1998. 121 later devices descend from it. It has been recalled 6 times.

Decided
Feb 20, 2004
Review
21 days
Class
Class II
Product code
JDS
Recalls
6
Predicates
5

Its longest line of descent runs back 1 generation to K981529 (1998). 5 ancestors in all. 121 later devices descend from it, 17 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestor2004: 1 descendant cleared2005: 2 descendants cleared2020: 7 descendants cleared2024: 15 descendants cleared2012: 3 descendants cleared2008: 2 descendants cleared2021: 6 descendants cleared2010: 1 descendant cleared2013: 7 descendants cleared2019: 2 descendants cleared2022: 9 descendants cleared2026: 12 descendants cleared2009: 3 descendants cleared2018: 6 descendants cleared2006: 1 descendant cleared2023: 9 descendants cleared2014: 4 descendants cleared2025: 16 descendants cleared2017: 5 descendants cleared2011: 4 descendants cleared2015: 4 descendants cleared2007: 1 descendant cleared2016: 1 descendant clearedK981529 · Titanium Intramedullary Nail, Titanium Locking Screw · Smith & Nephew, Inc. · 1998 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 17 descendants2 generations forward: 21 descendants3 generations forward: 26 descendants4 generations forward: 24 descendants5 generations forward: 18 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant K981529 · Titanium Intramedullary Nail, Titanium Locking Screw · Smith & Nephew, Inc. · 1998 · recalled0+5
  1. Root · 1 generation backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
  2. This deviceK040212 Trigen IntertanSmith & Nephew, Inc. · 2004
  3. Descendant · cites it directly · 69 of its ownK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
  4. Descendant · 2 generations on · 60 of its ownK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
  5. Descendant · cites it directly · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
  6. Descendant · 2 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
  7. Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 12008: 22009: 32010: 12011: 42012: 32013: 72014: 42015: 42016: 12017: 52018: 62019: 22020: 72021: 62022: 92023: 92024: 152025: 162026: 12
2004high 16 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 121 · See all
  • K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005 · cites it directly69descendants
  • K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · 2 generations on60descendants
  • K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · cites it directly35descendants
  • K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 2 generations on34descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K981529Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc.19982
0 (this device)K040212Trigen IntertanSmith & Nephew, Inc.2004—
+1K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.2005—
+2K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.20061
+1K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.2008—
+2K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.2009—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200710
200820
200930
201010
201140
201230
201370
201440
201540
201610
201750
201860
201920
202070
202160
202290
202390
2024150
2025160
2026120
FIG. 1 — Lineage of K040212, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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
*K981529Titanium Intramedullary Nail, Titanium Locking Screw
Summary page 1
…ies in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax…
Smith & Nephew, Inc.19982
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 1
…ional principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric…
Smith & Nephew, Inc.1999—
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 1
…tion to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780). DEP…
Smith & Nephew, Inc.1998—
*K013524Trochanteric Dyax Nail System
Summary page 1
…anium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Howmedica Osteonics Corp.2001—
*K010780Trochanteric Nail
Summary page 1
…Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
DePuy Orthopaedics, Inc.200184

Also cleared against K981529: 15 other devices →

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569
K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835
K200869Gamma3 SystemStryker Trauma GmbH20209
K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049
K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057
K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196
K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.20104
K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123
K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083
K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 22, 2022Class IIZ-1133-2022Under Investigation by firmRight nails were anodized, marked, and labelled as left nails and vice versa
Nov 2, 2020Class IIZ-0772-2021Packaging process controlManufacturing packaging error.
Oct 24, 2017Class IIZ-0097-2018Employee errorA single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Jul 2, 2014Class IIZ-2258-2014Under Investigation by firmThere was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
Apr 4, 2014Class IIZ-1636-2014Process controlA manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Apr 4, 2014Class IIZ-1637-2014Process controlA manufacturing error resulted in the set screw being inserted too deep in the affected nails.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K051557 (Smith & Nephew, Inc., 2005) has gone furthest, with 69 descendants of its own.
  • 15 other devices also cite its predicate K981529.

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?

InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K981529

15 other devices cite the same predicate.

  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023
  • K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 20224 recalls
  • K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 20121 recall
  • K111025Trigen Low Profile Bone ScrewSmith & Nephew, Inc. · 20111 recall
  • K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp. · 2010
  • K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 20101 recall

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K040212 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040212: Trigen Intertan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040212

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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