# K092190: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 11, 2010 after 294 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.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices 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) Synthes Distraction Osteogenesis System: named in the summary without a submission number
- (no number) Synthies Large External Fixation, MR Conditional: named in the summary without a submission number

## Most influential descendants
- K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System (2016), 8 descendants of its own
- K191241: AutoStrut (2019), 4 descendants of its own
- K202810: AutoStrut G2 (2021), 3 descendants of its own
- K113695: Ellipse Precice Trauma Nail System (2012), 3 descendants of its own
- K211313: MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (2021), 2 descendants of its own

## Recalls of this device
- Apr 10, 2014 · Class II · Z-1833-2014: Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

## Indications for use
The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions 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 in adult and pediatric patients.

Source page: https://510kreport.com/device/K092190
Methodology: https://510kreport.com/methodology