# K241804: TRIGEN INTERTAN 10S Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 22, 2024 after 62 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981529 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 4.
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 4.

## Indications for use
The TRIGEN INTERTAN Nails are indicated for fractures of the femur including: Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures Polytrauma and multiple fractures Prophylactic nailing of impending pathologic fractures Reconstruction following tumor resection and grafting

Source page: https://510kreport.com/device/K241804
Methodology: https://510kreport.com/methodology