# K221621: Pro-X1™ Trochanteric Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: X-Bolt Orthopedics
- Decided: Mar 6, 2023 after 276 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: 8 generations back to K970097 (1997). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181640: X-BOLT Hip Fracture Fixation System, X-Bolt Orthopaedics (2018) Summary page 5.

## Indications for use
The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in: Intertrochanteric and subtrochanteric fractures Segmental fractures Comminuted fractures Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union, and delayed union Surgically created defects such as osteotomies

Source page: https://510kreport.com/device/K221621
Methodology: https://510kreport.com/methodology