# K150771: RxG Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Aug 27, 2015 after 156 days
- Product code: PBJ (Cranial Distraction System)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K002083: Lorenz Resorbable Distractor System, Walter Lorenz Surgical, Inc. (2001). Our reading of the summary gave K002083, FDA’s number for Lorenz Resorbable Distractor System (Walter Lorenz Surgical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “LactoSorb Distraction”. Kept off the family tree. Summary page 4.

## 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 in cranial reconstruction for the pediatric and adult populations.

Source page: https://510kreport.com/device/K150771
Methodology: https://510kreport.com/methodology