# K182154: Depuy Synthes Femoral Neck System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Oct 16, 2018 after 68 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 5 generations back to K981372 (1998). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112406: Peri-Loc Proximal Femur Locking Bone Plates, Smith & Nephew, Inc. (2011) Summary page 4.
- K062066: Omega 3 System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K172872: DePuy Synthes Femoral Neck System, DePuy Synthes (2018) Summary page 4.

## Most influential descendants
- K230764: OsteoCentric Integrated Hip Fastener System (2023), 0 descendants of its own

## Indications for use
The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

Source page: https://510kreport.com/device/K182154
Methodology: https://510kreport.com/methodology