# K040284: Sustain Radiolucent Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Mar 23, 2004 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: 4 generations back to K003275 (2001). 4 ancestors in all.
906 later devices descend from it; 10 cite it directly.
1 of 911 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031302: Sustain Spacer, Globus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K051205: Stryker Spine Avs Asl Peek Spacer (2005), 829 descendants of its own
- K060762: Aesculap Peek Vertebral Body Replacement System (2006), 789 descendants of its own
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), 554 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own

## Indications for use
The Sustain Radiolucent 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 Sustain Radiolucent Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. The Sustain Radiolucent 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/K040284
Methodology: https://510kreport.com/methodology