# K233696: DePuy Synthes Retrograde Femoral Nail Advanced System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Aug 1, 2024 after 258 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K000089 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm, Synthes (USA) Products, LLC (2020) Summary page 4.
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own

## Indications for use
The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - Supracondylar fractures, including those with intra-articular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and nonunions

Source page: https://510kreport.com/device/K233696
Methodology: https://510kreport.com/methodology