# K043052: Trigen Hindfoot Fusion Nail

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 24, 2004 after 19 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950394 (1995). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950394: Tibia-Talus-Calcaneus Nail, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K991790: Ultimax Ankle Fusion Rod System, Encore Orthopedics, Inc. (1999) Summary page 1.

## Most influential descendants
- K102413: Fuze: Intramedullary Internal Fixation Nail (2011), 7 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own
- K251850: Phantom® Hindfoot TTC/TC Nail System (2025), 1 descendant of its own

## Recalls of this device
- Apr 22, 2008 · Not classified · Z-2087-2008: 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: 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: 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: 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: 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: 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: One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.

## Indications for use
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.

Source page: https://510kreport.com/device/K043052
Methodology: https://510kreport.com/methodology