# K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Feb 2, 2021 after 88 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: 24 generations back to K841189 (1984). 454 ancestors in all.
35 later devices descend from it; 8 cite it directly.
1 of 490 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201087: CORBEL Spacers, Globus Medical, Inc. (2020) Summary page 9.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 9.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 9.
- 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 9.
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 9.
- K170157: INDEPENDENCE® Spacers, Globus Medical, Inc. (2017) Summary page 9.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 9.
- K142498: MAGNIFY and MAGNIFY-S Spacers, Globus Medical, Inc. (2015) Summary page 9.
- K132559: Monument Spacers, Globus Medical, Inc. (2013) Summary page 9.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 9.
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers, Globus Medical, Inc. (2016) Summary page 9.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 9.
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, Ldr Spine USA (2016) Summary page 9.
- K181386: NuVasive Brigade Lateral System, Nu Vasive, Incorporated (2018) Summary page 9.
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020) Summary page 9.

## Most influential descendants
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K212498: Stable-L Standalone Lumbar Interbody System (2022), 7 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 5 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own

## Indications for use
INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices 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), 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 INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions. INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant. INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer. All INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices 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), 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. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant. HEDRON IA™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The MAGNIFY®-S 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), 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®-S Spacer is to be used with or without three screws which accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when used with three screws per implant. The MAGNIFY®-S Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. 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 1 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. 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. InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices 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), 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 InterContinental® TPS coated spacers are indicated for the same use as non-coated PEEK versions. InterContinental® Plate-Spacers are intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). InterContinental® Plate-Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The ELSA® 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), 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 ELSA® Spacer is intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation. Hyperlordotic (>20°) implants must be used with the two screws and/or anchors and supplemental fixation in addition to the two screws and/or anchors. The ELSA® Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K203278
Methodology: https://510kreport.com/methodology