# K120083: Set Screw for TI Trochanteric Fixation Nail (TFN)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Feb 8, 2012 after 28 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). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092646: Synthes (Usa) Trochanteric Fixation Nail (TFN) Screw, Synthes (Usa) (2009) Summary page 1.
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001)
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.

## Most influential descendants
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants of its own
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
The Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof The long TEN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Source page: https://510kreport.com/device/K120083
Methodology: https://510kreport.com/methodology