# K040462: Trigen Trochanteric Antegrade Nail

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 23, 2004 after 29 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981529 (1998). 2 ancestors in all.
13 later devices descend from it; 6 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)
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K092748: Sureshot Tan Nails and Accessories (2010), 4 descendants of its own
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K172157: DePuy Synthes Femoral Recon Nail System (2017), 2 descendants of its own
- K243364: TRIGEN META-TAN Trochanteric Antegrade Nail (2024), 1 descendant of its own
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own

## Recalls of this device
- Jul 24, 2023 · Class II · Z-2443-2023: 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
- Jul 24, 2023 · Class II · Z-2444-2023: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K040462
Methodology: https://510kreport.com/methodology