# K240061: TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 20, 2024 after 255 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: 4 generations back to K951740 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 6.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 6.

## Indications for use
TRIGEN MAX Tibial Nail System: The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft. INTERTAN MAX Hip Fracture Nail System: The INTERTAN MAX 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 fracture; 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/K240061
Methodology: https://510kreport.com/methodology