# K070181: Sintea Biotech DSC/Alf Spinal System,   DSC.XX.T5.XX, Alf.XX.T5.XX

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Apr 18, 2007 after 89 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: 1 generation back to K003155 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K101886: DSC/Alf Spinal System (2011), 0 descendants of its own

## Indications for use
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF system is intended to be used with bone graft.

Source page: https://510kreport.com/device/K070181
Methodology: https://510kreport.com/methodology