# K113383: Xtrafix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Extraortho, Inc.
- Decided: Jun 26, 2012 after 223 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: 3 generations back to K994143 (2000). 7 ancestors in all.
8 later devices descend from it; 5 cite 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 1.
- K111155: Xtrafix External Fixation System, Extraortho, Inc. (2011) Summary page 1.
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe, Synthes (Usa) (2003) Summary page 2.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 2.

## Most influential descendants
- 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
- K223112: MAVERICK Mini External Fixation System (2022), 0 descendants of its own

## Indications for use
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for: o Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; o Arthrodesis and osteotomies with associated soft tissue problems; o Stabilization of limbs after removal of total joint arthroplasty for infection or other failure; o Stabilization of non-unions; and o Intraoperative temporary stabilization tool to assist with indirect reduction.

Source page: https://510kreport.com/device/K113383
Methodology: https://510kreport.com/methodology