# K101886: DSC/Alf Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Plastek, LLC
- Decided: Jul 21, 2011 after 380 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: 2 generations back to K003155 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070181: Sintea Biotech DSC/Alf Spinal System,   DSC.XX.T5.XX, Alf.XX.T5.XX, Sintea Biotech, Inc. (2007)

## 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 spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PbS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autografi.

Source page: https://510kreport.com/device/K101886
Methodology: https://510kreport.com/methodology