# K002083: Lorenz Resorbable Distractor System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Feb 12, 2001 after 217 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011569: Biosorbfx O/M 2.0/2/4 System (2002), 5 descendants of its own
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K030425: Lorenz Resorbable Distraction System or Expander (2004), 1 descendant of its own
- K133304: RXG Distraction System (2014), 0 descendants of its own

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0383-2012: Lorenz Engineer discovered flex tube could break if bent too much.
- Feb 17, 2006 · Not classified · Z-0384-2012: Lorenz Engineer discovered flex tube could break if bent too much.
- Feb 17, 2006 · Not classified · Z-0385-2012: Lorenz Engineer discovered flex tube could break if bent too much.

Source page: https://510kreport.com/device/K002083
Methodology: https://510kreport.com/methodology