# K191391: HEDRON Lumbar Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Sep 18, 2019 after 117 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: 21 generations back to K841189 (1984). 292 ancestors in all.
84 later devices descend from it; 19 cite it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170157: INDEPENDENCE® Spacers, Globus Medical, Inc. (2017) Summary page 4.
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers, Globus Medical, Inc. (2018) Summary page 4.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- 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
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K202034: aprevo Intervertebral Body Fusion Device (2020), 17 descendants of its own

## Indications for use
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 (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (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 TA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). HEDRON IA™ 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 three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Source page: https://510kreport.com/device/K191391
Methodology: https://510kreport.com/methodology