# 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

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 13, 2016 after 483 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: 14 generations back to K003155 (2001). 115 ancestors in all.
210 later devices descend from it; 8 cite it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133967: Interbody Cage System, Aurora Spine (2014) Summary page 6.
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 7.
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 7.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 7.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 7.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 7.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 7.
- K102313: Patriot Transcontinental M Spacers, Globus Medical, Inc. (2010) Summary page 7.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 7.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 7.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 7.
- K131449: Coalition Spacer, Globus Medical, Inc. (2013) Summary page 7.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 7.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 7.
- K112756: Fortify (TM) and Fortify (TM)-R Corpectomy Spacers, Globus Medical, Inc. (2011) Summary page 7.
- K121107: Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R), Globus Medical, Inc. (2012) Summary page 7.
- K060665: Xpand Radiolucent Corpectomy Spacer, Globus Medical, Inc. (2006) Summary page 7.
- K072465: Niko Corpectomy Spacer, Globus Medical, Inc. (2007) Summary page 7.

## Most influential descendants
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own
- K170157: INDEPENDENCE® Spacers (2017), 109 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer (2018), 94 descendants of its own
- K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own

## Indications for use
SUSTAIN® Spacers When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® 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. SUSTAIN® 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 Systems. When used as vertebral body replacement devices, SUSTAIN® 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 spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. PATRIOT® Lumbar Spacers PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices 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 as 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). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation. PATRIOT® Cervical Spacers PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices 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 as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems. CALIBER® Spacers CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices 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). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. COALITION® Spacers COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices 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. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants. INDEPENDENCE® Spacers INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices 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). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants. FORTIFY® Corpectomy Spacers FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices 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). These devices 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 spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. XPand® Corpectomy Spacers XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices 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). XPand® Corpectomy 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 system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. NIKO® Corpectomy Spacers NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices 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). NIKO® Corpectomy 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 spacers can be packed with bone grafting material. NIKO® Corpectomy 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/K143578
Methodology: https://510kreport.com/methodology