# K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Sep 23, 2020 after 125 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 K000089 (2000). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 4.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K233696: DePuy Synthes Retrograde Femoral Nail Advanced System (2024), 1 descendant of its own
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0228-2026: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packag
- Sep 26, 2025 · Class II · Z-0229-2026: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packag

## 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 The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

Source page: https://510kreport.com/device/K201346
Methodology: https://510kreport.com/methodology