# K201087: CORBEL Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 31, 2020 after 99 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 22 generations back to K841189 (1984). 294 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 331 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 4.
- K181386: NuVasive Brigade Lateral System, Nu Vasive, Incorporated (2018) Summary page 4.

## Most influential descendants
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers (2021), 35 descendants of its own
- 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

## Indications for use
CORBEL™ Spacers 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. CORBEL™ 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. CORBEL™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K201087
Methodology: https://510kreport.com/methodology