# K031181: External Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 14, 2003 after 90 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: 1 generation back to K994143 (2000). 1 ancestor in all.
24 later devices descend from it; 9 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.

## Most influential descendants
- K113327: Hoffmann LRF (Limb Reconstruction Frame) System (2012), 17 descendants of its own
- K130907: Hoffmann LRF (Limb Reconstruction Frame) System (2013), 15 descendants of its own
- K130334: Hoffmann LRF (Limb Reconstruction Frame System) (2013), 15 descendants of its own
- K140961: Hoffmann LRF (Limb Reconstruction Frame) System (2014), 14 descendants of its own
- K153377: Hoffmann LRF (Limb Reconstruction Frame) System (2016), 13 descendants of its own

## Indications for use
External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.

Source page: https://510kreport.com/device/K031181
Methodology: https://510kreport.com/methodology