# K014145: Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Model 8130, 8131

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Jan 17, 2002 after 30 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 K010989 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010989: Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130, 8131, Interpore Cross Intl. (2001)

## Indications for use
The Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and jumbar spine. The TPS-TL Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K014145
Methodology: https://510kreport.com/methodology