# K111155: Xtrafix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Extraortho, Inc.
- Decided: Oct 20, 2011 after 178 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 2 generations back to K994143 (2000). 6 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091258: Extrafix External Fixation System, Qfx Technologies, Inc. (2009) Summary page 2.
- K053472: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 2.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 2.

## Most influential descendants
- K113383: Xtrafix External Fixation System (2012), 8 descendants of its own
- K181528: Austin Miller Large External Fixation System (2019), 2 descendants of its own
- K131413: Xtrafix Small External Fixation System (2014), 2 descendants of its own
- K213874: MAVERICK External Fixation System (2022), 1 descendant of its own
- K141697: Xtrafix External Fixation System, Xtrafix Small External Fixation System (2014), 1 descendant of its own

## Indications for use
The Xtrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins. The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for: Temporary stabilization of open or closed acute fractures with soft tissue injuries; Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated; Stabilization of fractures in the context of polytrauma; Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; Arthrodesis and osteotomies with associated soft tissue problems; Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure; Neutralization of fractures stabilized with limited internal fixation; Stabilization of non-unions; and Intraoiperative temporary stabilization tool to assist with indirect reduction.

Source page: https://510kreport.com/device/K111155
Methodology: https://510kreport.com/methodology