# K133304: RXG Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: May 15, 2014 after 199 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904436 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030425: Lorenz Resorbable Distraction System or Expander, Walter Lorenz Surgical, Inc. (2004) Summary page 1.
- K002083: Lorenz Resorbable Distractor System, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K112064: Resorb X-G, KLS-Martin L.P. (2012) Summary page 1.
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 1.

## Indications for use
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge. The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger. The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.

Source page: https://510kreport.com/device/K133304
Methodology: https://510kreport.com/methodology