# K063832: Synthes (Usa) Elbow Hinge Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 7, 2007 after 71 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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.
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) Stryker-Dynanico Joint Distractor II: named in the summary without a submission number

## Indications for use
The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must 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 for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults.

Source page: https://510kreport.com/device/K063832
Methodology: https://510kreport.com/methodology