# K030425: Lorenz Resorbable Distraction System or Expander

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: May 14, 2004 after 459 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: 1 generation back to K955729 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002083: Lorenz Resorbable Distractor System, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K992952: Lorenz Distraction System, Walter Lorenz Surgical, Inc. (1999) Summary page 2.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K981666: 2.5 MM Lactosorb Screws, Biomet, Inc. (1998) Summary page 1.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 2.

## Most influential descendants
- K133304: RXG Distraction System (2014), 0 descendants of its own

## Indications for use
The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) when correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone distraction. The Lorenz Resorbable Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of mandibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.

Source page: https://510kreport.com/device/K030425
Methodology: https://510kreport.com/methodology