# K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Dec 6, 2018 after 198 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: 20 generations back to K841189 (1984). 275 ancestors in all. 97 later devices descend from it; 2 cite it directly. 0 of 373 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 5. - K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 5. - K102313: Patriot Transcontinental M Spacers, Globus Medical, Inc. (2010) Summary page 5. - K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 5. - 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, Globus Medical, Inc. (2016) Summary page 5. - 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, Globus Medical, Inc. (2017) Summary page 5. - K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers, Globus Medical, Inc. (2016) Summary page 5. - K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 5. - K151665: SUSTAIN Additional Implants, Globus Medical, Inc. (2016) Summary page 5. - K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 5. - K170962: NuVasive® CoRoent® Thoracolumbar System, Nu Vasive, Incorporated (2017) Summary page 5. - K100865: Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX, Stryker Spine (2010) Summary page 5. - K171031: CRESCENT™ Spinal System, Medtronic Sofamor Danek (2017) Summary page 5. ## Most influential descendants - K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own - K192115: SABLE Expandable Spacer (2020), 37 descendants of its own - K201087: CORBEL Spacers (2020), 36 descendants of its own - K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers (2021), 35 descendants of its own - K201671: A-Link Z (2021), 25 descendants of its own ## Indications for use PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions. When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions. Source page: https://510kreport.com/device/K181357 Methodology: https://510kreport.com/methodology