# K041798: Atalia Titanium Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Us Spinal Technologies, LLC
- Decided: Feb 7, 2005 after 220 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: 3 generations back to K841189 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K030744: Blackstone Surgical Titanium Mesh, Blackstone Medical, Inc. (2003) Summary page 1.

## Indications for use
The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (TI-L5), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

Source page: https://510kreport.com/device/K041798
Methodology: https://510kreport.com/methodology