# K024364: Synthes Vertebral Spacer TI (Curved and Narrow)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 17, 2003 after 76 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 K003275 (2001). 2 ancestors in all.
1,683 later devices descend from it; 7 cite it directly.
1 of 1,686 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020152: Synthes Vertebral Spacer TI, Synthes (Usa) (2002)

## Most influential descendants
- K040482: Ebi Esl Spine Spacer System (2004), 1,621 descendants of its own
- K042268: Ebi Cas Spine Spacer System (2004), 1,620 descendants of its own
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) (2005), 1,571 descendants of its own
- K042930: Spacevision Cage System (2004), 1,440 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 descendants of its own

## Indications for use
The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone. The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K024364
Methodology: https://510kreport.com/methodology