# K160167: DePuy Synthes TFNA Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Sep 26, 2016 after 243 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 K961213 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961213: Alta Dome and Plunger (Mec Hip Bolt), Howmedica Corp. (1996) Summary page 4.

## Recalls of this device
- Jan 24, 2024 · Class II · Z-1239-2024: Products not sterilized, sterility cannot be confirmed
- Jan 24, 2024 · Class II · Z-1240-2024: Products not sterilized, sterility cannot be confirmed

## Indications for use
The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically the system is indicated for: • Stable and unstable pertrochanteric fractures • Intertrochanteric fractures • Basal neck fractures • Combinations of pertrochanteric, intertrochanteric, and basal neck fractures The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12- 21) in which the growth plates have fused for the following indications: • 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 Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.

Source page: https://510kreport.com/device/K160167
Methodology: https://510kreport.com/methodology