# K070294: Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Mar 1, 2007 after 29 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Trochanteric Fixation Nail (TFN) System: named in the summary without a submission number

## 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
- K233150: NET BRAND Osteosynthesis Nailing System (2024), 0 descendants of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Recalls of this device
- Oct 3, 2013 · Class II · Z-0369-2014: A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

## Indications for use
Synthes Trochanteric Fixation Nail (TFN) System 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 TFN 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/K070294
Methodology: https://510kreport.com/methodology