# K093207: Enduramesh, Model 762.XXX

- Pathway: 510(k) (Traditional)
- Applicant: Lucero Medical, LLC
- Decided: Apr 26, 2010 after 195 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841189 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K122622: Enduramesh (2012), 0 descendants of its own

## Recalls of this device
- Jul 15, 2012 · Class II · Z-2368-2012: The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.

## 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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

Source page: https://510kreport.com/device/K093207
Methodology: https://510kreport.com/methodology