# K233134: I.T.S. INS Proximal Femur Nail

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Feb 12, 2024 after 138 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: 9 generations back to K970097 (1997). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200869: Gamma3 System, Stryker Trauma GmbH (2020) Summary page 4.

## Indications for use
The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails. The indications for use of the I.T.S. INS Proximal Femur include: All Nails: • Stable and unstable pertrochanteric fractures • Intertrochanteric fractures • Combinations of fractures listed above Additionally for Long Nails: • Subtrochanteric fractures • Proximal fractures as listed above associated with shaft fractures • Pathological fractures in regions as listed above • Nonunions and malunions in regions as listed above

Source page: https://510kreport.com/device/K233134
Methodology: https://510kreport.com/methodology