# K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 12, 2001 after 90 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 7 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica Gamma® Nail System, including modifications for the Long Length and Short Length Gamma® Nails: named in the summary without a submission number

## Most influential descendants
- K120083: Set Screw for TI Trochanteric Fixation Nail (TFN) (2012), 3 descendants of its own
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants of its own
- K151010: Piccolo Composite Nailing System (2015), 2 descendants of its own
- K153536: Piccolo Composite® Nailing System (2016), 1 descendant of its own
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own

## Recalls of this device
- Jul 21, 2017 · Class II · Z-0604-2018: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
- Nov 2, 2015 · Class II · Z-0375-2016: TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a lo
- Oct 29, 2014 · Class II · Z-0219-2015: The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operativ
- Jul 31, 2013 · Class II · Z-0387-2014: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
- Jul 30, 2013 · Class II · Z-0452-2014: Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
- Jul 30, 2013 · Class II · Z-0474-2014: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
- Nov 2, 2012 · Class II · Z-2058-2013: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external 

## 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/K011857
Methodology: https://510kreport.com/methodology