# K090658: Synthes External Fixation Devices, MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 3, 2010 after 356 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.
15 later devices descend from it; 5 cite it directly.
0 of 16 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 Medium External Fixation: named in the summary without a submission number
- (no number) Synthes Distal Radius Fixator: named in the summary without a submission number
- (no number) Synthes Low Profile Wrist Fixator: named in the summary without a submission number
- (no number) Synthes Elbow Hinge Fixator: named in the summary without a submission number
- (no number) Synthes Large External Fixation, MR Conditional: named in the summary without a submission number

## Most influential descendants
- K113770: Orthofix Galaxy Fixation System (2012), 6 descendants of its own
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System (2013), 3 descendants of its own
- K181528: Austin Miller Large External Fixation System (2019), 2 descendants of its own
- K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit (2014), 2 descendants of its own
- K213874: MAVERICK External Fixation System (2022), 1 descendant 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
Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures- Synthes Distal Radius Fixator is intended for the fixation of the distal radius. Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius. Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress musi be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are: * Delayed treatment of dislocated and stiff elbows * Chronic, persistent joint instability * Acute joint instability after complex ligament injuries * Unstable elbow fractures * Additional stabilization of post-operative unstable internal fixation The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator System for adults (rod diameter: 011Imm), and with components of the Synthes Medium External Fixator System (rod diameter: 08mm) for children and.small stature adults.

Source page: https://510kreport.com/device/K090658
Methodology: https://510kreport.com/methodology