# K131413: Xtrafix Small External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 28, 2014 after 257 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: 4 generations back to K994143 (2000). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113383: Xtrafix External Fixation System, Extraortho, Inc. (2012) Summary page 1.
- K984357: Transfx External Fixation System, Immedica, Inc. (1999) Summary page 1.
- K990848: Transfx Intermediate External Fixation System,Transfx Small External Fixation System, Transfx Mini External Fixation, Immedica, Inc. (1999) Summary page 1.
- K031724: Synthes Small Cobination Clamp-MR Safe, Synthes (Usa) (2003) Summary page 1.
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 1.

## Most influential descendants
- K141697: Xtrafix External Fixation System, Xtrafix Small External Fixation System (2014), 1 descendant of its own
- K152484: FastFrame External Fixation System - Distal Radius (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K131413
Methodology: https://510kreport.com/methodology