# K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Oct 21, 2022 after 84 days - Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical) - 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). 914 ancestors in all. 23 later devices descend from it; 10 cite it directly. 4 of 938 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 8. - K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 8. - K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 8. - K192115: SABLE Expandable Spacer, Globus Medical, Inc. (2020) Summary page 8. - K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 8. ## Most influential descendants - 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 - K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own - K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own - K243802: aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (2025), 3 descendants of its own ## Indications for use HEDRON C® Spacers and HEDRON IC® Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. HEDRON C® Spacers and HEDRON IC® Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When the HEDRON IC® Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC® Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws. HEDRON® Lumbar Spacers (HEDRON A™, HEDRON L®, HEDRON P®, HEDRON T™, and HEDRON RT™) are lumbar 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. HEDRON® 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. 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. 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 ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers. Source page: https://510kreport.com/device/K222270 Methodology: https://510kreport.com/methodology