# K131548: Synthes Trochanteric Fixation Nail - Advanced System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Feb 28, 2014 after 274 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K192003: Auxein Nailing System (2020), 2 descendants of its own
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants of its own
- K171108: AUTOBAHN Nailing System (2017), 2 descendants of its own
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own

## 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
- Feb 1, 2023 · Class II · Z-1246-2023: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
- Feb 1, 2023 · Class II · Z-1248-2023: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
- Feb 1, 2023 · Class II · Z-1247-2023: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
- Sep 21, 2015 · Class II · Z-0126-2016: Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of t
- Jun 10, 2015 · Class II · Z-2091-2015: The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 0
- Apr 9, 2015 · Class II · Z-1600-2015: TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
- Feb 24, 2015 · Class II · Z-1352-2015: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Source page: https://510kreport.com/device/K131548
Methodology: https://510kreport.com/methodology