# K100043: Coroent XLR Standalone System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jun 16, 2010 after 159 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: 12 generations back to K841189 (1984). 64 ancestors in all.
744 later devices descend from it; 11 cite it directly.
1 of 809 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K081501: Solitaire Anterior Spinal System, Biomet Spine (2008) Summary page 1.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 1.

## Most influential descendants
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own

## Indications for use
When used as an intervertebral body fusion device: The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System. When used as a partial Vertebral Body Replacement (VBR): The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K100043
Methodology: https://510kreport.com/methodology