# K130478: Sustain and Sustain Radiolucent Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 26, 2013 after 151 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 29 ancestors in all.
256 later devices descend from it; 12 cite it directly.
1 of 286 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 1.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 1.
- K031302: Sustain Spacer, Globus Medical, Inc. (2003) Summary page 1.
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.

## Most influential descendants
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K142218: Coalition AGX Plate and Coalition AGX Spacer (2015), 155 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K151665: SUSTAIN Additional Implants (2016), 119 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own

## Indications for use
When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems. When used as a cervical intervertebral body fusion device, the SUSTAIN® and SUSTAIN® R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate System. When used as a vertebral body replacement device, SUSTAIN® and SUSTAIN® R Spacers are 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 spacers are 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. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K130478
Methodology: https://510kreport.com/methodology