# K243608: TRIGEN Stable Lock Nut & Washer

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 12, 2025 after 202 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: 6 generations back to K981529 (1998). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 6.
- K111025: Trigen Low Profile Bone Screw, Smith & Nephew, Inc. (2011) Summary page 6.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 6.
- K230761: TRIGEN META-NAIL Nail System, Smith & Nephew, Inc. (2023) Summary page 6.
- K243364: TRIGEN META-TAN Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2024). Cleared while this submission was under review Summary page 6.

## Indications for use
The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer. TRIGEN META-TAN Trochanteric Antegrade Nailing System The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures. TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the 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 (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures. TRIGEN META-NAIL Retrograde Femoral Nail System The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

Source page: https://510kreport.com/device/K243608
Methodology: https://510kreport.com/methodology