# K230761: TRIGEN META-NAIL Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 14, 2023 after 86 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: 4 generations back to K951740 (1995). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails, Smith & Nephew, Inc. (2005) Summary page 4.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 4.
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 4.

## Most influential descendants
- K253517: Reselute Tibial Nail (2026), 0 descendants of its own
- K243608: TRIGEN Stable Lock Nut & Washer (2025), 0 descendants of its own

## Indications for use
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. The TRIGEN META-NAIL Antegrade Tibial Nail is indicated for stable and unstable fractures of the proximal and distal third of the tibia, including the shaft.

Source page: https://510kreport.com/device/K230761
Methodology: https://510kreport.com/methodology