# K010344: Adjustable Large Fixator System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 3, 2001 after 87 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“KO0344”).
- (no number) Synthes Large External Fixator: named in the summary without a submission number

## Most influential descendants
- K110965: Renovis T 710 Large External Fixation System (2011), 2 descendants of its own
- K012623: Reprocessed External Fixation Device (2002), 1 descendant of its own
- K213905: ONX Large External Fixation System (2022), 0 descendants of its own
- K171211: OIC External Fixation System (2017), 0 descendants of its own
- K032058: Modification to Reprocessed Synthes External Fixation Devices (2003), 0 descendants of its own

## Indications for use
The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.

Source page: https://510kreport.com/device/K010344
Methodology: https://510kreport.com/methodology