# K181640: X-BOLT Hip Fracture Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Bolt Orthopaedics
- Decided: Oct 12, 2018 after 113 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: 7 generations back to K970097 (1997). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 4.
- K091566: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2009) Summary page 4.
- K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short, Zimmer GmbH (2012) Summary page 4.
- K050226: Asian Intramedullary Hip Screw Nails, Smith & Nephew, Inc. (2005) Summary page 4.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 4.
- K921786: Intramedullary Hip Screw, Smith & Nephew Richards, Inc. (1992) Summary page 4.
- K895241: Intramedullary Hip Screw, Richards Medical Co., Inc. (1990) Summary page 4.
- K062066: Omega 3 System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access, Smith & Nephew, Inc. (2007) Summary page 5.

## Most influential descendants
- K221621: Pro-X1™ Trochanteric Nailing System (2023), 0 descendants of its own

## Indications for use
The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip 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 The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in: • Intracapsular and extracapsular fractures of the femoral neck • Trochanteric fractures of the proximal femur • Stable subtrochanteric fractures of the proximal femur

Source page: https://510kreport.com/device/K181640
Methodology: https://510kreport.com/methodology