# K051600: Synthes (Usa) Distraction  Osteogenesis System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 27, 2005 after 41 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Ilizarov External Fixation System: named in the summary without a submission number
- (no number) Encore True/Lok External Fixation System: named in the summary without a submission number

## Recalls of this device
- Feb 9, 2009 · Not classified · Z-1324-2009: Numbers are etched incorrectly on the product.

## Indications for use
The Synthes Distraction Osteogenesis System is intended for fracture fixation (open and closed), pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects.

Source page: https://510kreport.com/device/K051600
Methodology: https://510kreport.com/methodology