# K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 30, 2005 after 17 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951740 (1995). 8 ancestors in all.
69 later devices descend from it; 6 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.
- K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 1.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.

## Most influential descendants
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), 60 descendants of its own
- K111667: Synthes Suprapatellar Insertion Instruments (2011), 18 descendants of its own
- K131365: T2 Tibial Nailing System (2013), 17 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own

## Indications for use
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathotogic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedultary nails are indicated for fixation of fractures that occur inand between the proximal and distal third of tong bones being treated. Inaddition to the indications for interlocking intramedultary nails, devices that contain hotes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilaterat femoral shaft/neck fractures; and intertrochanteric fractures. Inaddition to indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants. Intramedultary locking nails (i.e. TriGen® Nails) are for single use only.

Source page: https://510kreport.com/device/K051557
Methodology: https://510kreport.com/methodology