510(k) · Cleared
Recalled · 2008Trigen Hindfoot Fusion 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 Nov 24, 2004 as substantially equivalent to K950394 (Smith & Nephew Richards, Inc., 1995) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1995. 13 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 24, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950394 (1995). 2 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK950394 Tibia-Talus-Calcaneus NailSmith & Nephew Richards, Inc. · 1995
- This deviceK043052 Trigen Hindfoot Fusion NailSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK102413 Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · cites it directly7descendants
- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 3 generations on5descendants
- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
- K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950394 | Tibia-Talus-Calcaneus Nail | Smith & Nephew Richards, Inc. | 1995 | — |
| 0 (this device) | K043052 | Trigen Hindfoot Fusion Nail | Smith & Nephew, Inc. | 2004 | — |
| +1 | K102413 | Fuze: Intramedullary Internal Fixation Nail | Vilex, Inc. | 2011 | 3 |
| +2 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +3 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +4 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
| +3 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K950394 | Tibia-Talus-Calcaneus NailSummary page 1…ions for use, design features, operational principles, and material composition to the following predicate devices - the Smith & Nephew, Inc. Tibia-Talus-Catcaneus Nail (K950394) and the Encore Orthopedics UltiMax Ankle Fusion Rod System (K(991790). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1995 |
| * | K991790 | Ultimax Ankle Fusion Rod SystemSummary page 1…position to the following predicate devices - the Smith & Nephew, Inc. Tibia-Talus-Catcaneus Nail (K950394) and the Encore Orthopedics UltiMax Ankle Fusion Rod System (K(991790). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1999 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 | 7 |
| K121575 | Oxford Ankle Fusion Nail (Afn) System | 2012 | 1 |
| K221221 | Advanced Intramedullary Nail System | 2022 | 0 |
| K210980 | Smith & Nephew Intramedullary Nail Systems | 2022 | 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 |
|---|---|---|---|---|
| Apr 22, 2008 | Not classified | Z-2087-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2086-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2083-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2084-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2082-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2088-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Apr 22, 2008 | Not classified | Z-2085-2008 | Process control | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K102413 (Vilex, Inc., 2011) has gone furthest, with 7 descendants of its own.
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?
The TriGen Hindfoot Fusion Nail (HFN) is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints. The TriGen HFN is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043052: Trigen Hindfoot Fusion Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043052
Report an extraction error
Are you the manufacturer?
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