# K122622: Enduramesh

- Pathway: 510(k) (Special)
- Applicant: Lucero Medical, LLC
- Decided: Sep 19, 2012 after 22 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: 4 generations back to K841189 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093207: Enduramesh, Model 762.XXX, Lucero Medical, LLC (2010) Summary page 1.

## Indications for use
The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (TI-SI) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.

Source page: https://510kreport.com/device/K122622
Methodology: https://510kreport.com/methodology