# K061891: Synex II

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Aug 18, 2006 after 46 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). 4 ancestors in all.
77 later devices descend from it; 3 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 2.

## Most influential descendants
- K142205: NuVasive X-CORE (R) Expandable VBR System (2015), 74 descendants of its own
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System (2015), 68 descendants of its own
- K152568: C-VBR (2016), 57 descendants of its own
- K162315: FORTIFY Corpectomy Spacers (2017), 55 descendants of its own
- K172032: Modulift Vertebral Body Replacement (VBR) System (2017), 46 descendants of its own

## Indications for use
The SynexTM II implant 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 Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS. The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.

Source page: https://510kreport.com/device/K061891
Methodology: https://510kreport.com/methodology