# K132830: Distalock Tibial IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Dgimed Ortho, Inc.
- Decided: Jan 6, 2014 after 118 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 10 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 1.

## Indications for use
Intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.

Source page: https://510kreport.com/device/K132830
Methodology: https://510kreport.com/methodology