# K172157: DePuy Synthes Femoral Recon Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Nov 14, 2017 after 119 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 K981529 (1998). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 4.
- K070843: Synthes Adolescent Lateral Entry Femoral Nail System, Synthes (Usa) (2007) Summary page 4.
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 4.

## Most influential descendants
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own
- K261043: AUTOBAHN™ Nailing System (2026), 0 descendants of its own

## Indications for use
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: - Subtrochanteric fractures - Ipsilateral neck/shaft fracturcs - Femoral shaft fractures - Impending pathologic fractures - Malunions and nonunions

Source page: https://510kreport.com/device/K172157
Methodology: https://510kreport.com/methodology