# K003836: Synthes Synex Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: May 29, 2001 after 168 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K841189 (1984). 3 ancestors in all.
1,330 later devices descend from it; 9 cite it directly.
1 of 1,334 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.

## Most influential descendants
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System (2004), 1,280 descendants of its own
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own
- K080728: LDR Spine Roi-C Implant (2008), 903 descendants of its own
- K083857: LDR Spine Roi-C Implant (2009), 902 descendants of its own
- K091088: LDR Spine Cervical Interbody Fusion System (2009), 901 descendants of its own

## Recalls of this device
- Sep 14, 2009 · Not classified · Z-0109-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0110-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0111-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0115-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0113-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0117-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0118-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0114-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0108-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0112-2010: loss of device height
- Sep 14, 2009 · Not classified · Z-0116-2010: loss of device height

## Indications for use
The SynEx™ Spacer 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™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynEx™ Spacer System can be packed with bone. The SynEx™ Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K003836
Methodology: https://510kreport.com/methodology