# K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Aug 3, 2023 after 399 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: 25 generations back to K841189 (1984). 525 ancestors in all. 2 later devices descend from it; 2 cite it directly. 1 of 528 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 10. - K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 10. - K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 10. - K171848: FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers, Globus Medical, Inc. (2017) Summary page 10. - K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 10. - K123913: Latis Spacer, Globus Medical, Inc. (2013) Summary page 10. - K140411: Altera Spacer, Globus Medical, Inc. (2014) Summary page 10. - K142498: MAGNIFY and MAGNIFY-S Spacers, Globus Medical, Inc. (2015) Summary page 10. - K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 10. - K192115: SABLE Expandable Spacer, Globus Medical, Inc. (2020) Summary page 10. - K132559: Monument Spacers, Globus Medical, Inc. (2013) Summary page 10. - K203038: Toro-L Interbody Fusion System, Integrity Implants, Inc. (2021) Summary page 10. - K213355: Toro-L Interbody Fusion System, Integrity Implants, Inc. (2022) Summary page 10. - K210214: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System, Nu Vasive, Incorporated (2021) Summary page 10. - K210439: NuVasive MOD-EX XLIF Interbody System, Nu Vasive, Incorporated (2021) Summary page 10. ## Most influential descendants - K253401: SCRIPT™ Implant System (2026), 0 descendants of its own - K234035: COSINE™ Spacer (2024), 0 descendants of its own ## Indications for use CALIBER® Spacers are interbody fusion devices intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK spacers. CALIBER® 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). The RISE® Spacer is an interbody fusion device intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The RISE® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. This device is 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). LATIS® Spacers are interbody fusion devices intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. LATIS® 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). The ALTERA® Spacer is an interbody fusion device intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The ALTERA® Spacer is 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). The MAGNIFY® Spacer is an interbody fusion device intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The MAGNIFY® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, and is 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). SABLE® Expandable Spacer is an interbody fusion device intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is 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). The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the 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), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 2 spondylolisthesis or retrolisthesis at the involved level(s). 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. All MONUMENT® TPS coated spacers are indicated for the same use as non-coated spacers. The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. Source page: https://510kreport.com/device/K221894 Methodology: https://510kreport.com/methodology