# K072326: Ostapek VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Co-Ligne AG
- Decided: Jun 24, 2008 after 309 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052384: Lanx VBR System, Lanx, LLC (2005) Summary page 1.
- K052746: Concorde VBR Spinal System, Depuy Spine, Inc. (2005) Summary page 1.
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 1.

## Most influential descendants
- K173893: Trabis (2018), 0 descendants of its own

## Indications for use
The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GIISpinal Fixation System.

Source page: https://510kreport.com/device/K072326
Methodology: https://510kreport.com/methodology