# K071795: Nuvasive Coroent System

- Pathway: 510(k) (Abbreviated)
- Applicant: Nuvasive, Inc.
- Decided: Dec 4, 2007 after 155 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: 1 generation back to K071922 (2007). 1 ancestor in all.
1,122 later devices descend from it; 42 cite it directly.
1 of 1,124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071922: Interplate Interbody Fusion Device, Models C, CGC, L and LGC, Rsb Spine, LLC (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K082128: Depuy Spine Lateral Cage System (2008), 933 descendants of its own
- K090899: Depuy Spine Lateral System (2009), 932 descendants of its own
- K093242: Patriot Transcontinental Llif Spacer (2009), 921 descendants of its own
- K102293: Caliber Spacer (2011), 869 descendants of its own
- K111512: Bonebac T-Plif Intervertebral Body Fusion Device System (2011), 762 descendants of its own

## Indications for use
Intervertebral Body Fusion The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Partial Vertebral Body Replacement The NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K071795
Methodology: https://510kreport.com/methodology