# K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 6, 2006 after 54 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951740 (1995). 9 ancestors in all.
60 later devices descend from it; 13 cite it directly.
0 of 70 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.
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails, Smith & Nephew, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own

## Recalls of this device
- Jun 24, 2020 · Class II · Z-2685-2020: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

## 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 pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/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; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. In addition 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. Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.

Source page: https://510kreport.com/device/K061019
Methodology: https://510kreport.com/methodology