510(k) Report

510(k) · Cleared

Cleared

Trigen Adolescent Tan

K040929510(k) TraditionalCleared May 25, 200446-day reviewClass II21 CFR 888.3020

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

Smith & Nephew, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 25, 2004 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.

Decided
May 25, 2004
Review
46 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K981529 (1998). 2 ancestors in all. 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2012: 1 descendant cleared2009: 1 descendant cleared2022: 2 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK981529 · Titanium Intramedullary Nail, Titanium Locking Screw · Smith & Nephew, Inc. · 1998 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants K981529 · Titanium Intramedullary Nail, Titanium Locking Screw · Smith & Nephew, Inc. · 1998 · recalled0
  1. Root · 1 generation backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
  2. This deviceK040929 Trigen Adolescent TanSmith & Nephew, Inc. · 2004
  3. Descendant · cites it directly · 6 of its ownK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK220679 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022
  6. Descendant · 3 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
  7. Descendant · 3 generations on · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12018: 22019: 12022: 22025: 12026: 1
2009high 2 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · cites it directly6descendants
  • K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · 2 generations on4descendants
  • K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022 · 3 generations on2descendants
  • K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 3 generations on0descendants
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)K040929Trigen Adolescent TanSmith & Nephew, Inc.2004—
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.200927
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.20183
+3K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.2022—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.2025—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201820
201910
202220
202510
202610
FIG. 1 — Lineage of K040929, 1998–2026Source: 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? (2)

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) and Intramedullary Nail System (K983942). I1n. DEPARTMENT OF HEALTH & HUMAN SERVICES…
Smith & Nephew, Inc.19982
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 1
…es, operational principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942). I1n. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health S…
Smith & Nephew, Inc.1998—

Also cleared against K981529: 15 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.20096
K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.20220
K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.20120

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K083726 (OrthoPediatrics Corp., 2009) has gone furthest, with 6 descendants of its own.
  • 15 other devices also cite its predicate K981529.

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?

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures…

Read the full statement (127 words)

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. TriGen Adolescent TAN 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 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/K040929 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040929: Trigen Adolescent Tan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040929

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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