# K954053: Berlin External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: May 16, 1996 after 261 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) Ilizarov device marketed by Smith-Nephew Richards: named in the summary without a submission number

## Indications for use
The Berlin External Fixator is a wire connected ring or frame fixator. It can be used as a static fixator or dynamically applying distraction or compression. The Berlin Fixator has been designed as a modular construction system. Through the use of a few individual components, simple static fixation procedures can be achieved. The range of indications includes treatment of acute fractures and reconstructive surgery of all long bones. This devices is made from a combination of aluminum and stainless steel.

Source page: https://510kreport.com/device/K954053
Methodology: https://510kreport.com/methodology