510(k) · Cleared
Recalled · Class II · 2023Trigen Trochanteric Antegrade Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 23, 2004 as substantially equivalent to K981529 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1998. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 23, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981529 (1998). 2 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- This deviceK040462 Trigen Trochanteric Antegrade NailSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK092748 Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · Recalled
- Descendant · cites it directly · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- Descendant · cites it directly · 2 of its ownK172157 DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK243364 TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · cites it directly4descendants
- K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · cites it directly2descendants
- K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC · 2017 · cites it directly2descendants
- K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024 · 2 generations on1descendant
- K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| 0 (this device) | K040462 | Trigen Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2004 | — |
| +1 | K092748 | Sureshot Tan Nails and Accessories | Smith & Nephew, Inc. | 2010 | 1 |
| +1 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| +1 | K172157 | DePuy Synthes Femoral Recon Nail System | Synthes (USA) Products, LLC | 2017 | — |
| +2 | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | 2024 | — |
| +2 | K220659 | AUTOBAHN (R) EVO Femoral Nails | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewSummary 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). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1998 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary 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). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1998 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092748 | Sureshot Tan Nails and Accessories | 2010 | 4 |
| K181296 | Syntec Femoral Nail System | 2019 | 2 |
| K172157 | DePuy Synthes Femoral Recon Nail System | 2017 | 2 |
| K253046 | HERA Interlocking Intramedullary Nailing System | 2026 | 0 |
| K241804 | TRIGEN INTERTAN 10S Nail System | 2024 | 0 |
| K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2023 | Class II | Z-2443-2023 | Process control | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described… |
| Jul 24, 2023 | Class II | Z-2444-2023 | Process control | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
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. Trochanteric Antegrade Nail is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040462: Trigen Trochanteric Antegrade Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040462
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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