# K010780: Trochanteric Nail

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 12, 2001 after 89 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 84 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
168 later devices descend from it; 6 cite it directly.
0 of 169 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
- K040212: Trigen Intertan (2004), 121 descendants of its own
- K013563: Long Trochanteric Nail System (2001), 70 descendants of its own
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails (2005), 69 descendants of its own
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), 60 descendants of its own
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems (2003), 53 descendants of its own

## Recalls of this device
- Dec 20, 2017 · Class II · Z-1226-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1229-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1230-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1234-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1228-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1231-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1225-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1232-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1235-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1227-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1233-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 11, 2003 · Not classified · Z-0465-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0445-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0467-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0471-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0424-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0421-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0475-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0469-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0428-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0477-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0472-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0464-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0437-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0434-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0481-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0441-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0463-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0446-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0423-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0470-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0420-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0473-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0444-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0468-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0426-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0476-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0430-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0478-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0429-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0480-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0438-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0435-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0482-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0474-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0425-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0483-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0447-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0466-04: The lag screw may migrate to the femoral head or into the abdominal cavity.
- Dec 11, 2003 · Not classified · Z-0443-04: The lag screw may migrate to the femoral head or into the abdominal cavity.

Source page: https://510kreport.com/device/K010780
Methodology: https://510kreport.com/methodology