# K160916: CoRoent® Ti-C System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 28, 2016 after 88 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: 18 generations back to K841189 (1984). 173 ancestors in all.
139 later devices descend from it; 3 cite it directly.
0 of 313 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014) Summary page 4.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 4.
- K153782: NuVasive® Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.

## Most influential descendants
- K162138: NuVasive CoRoent Small Ti-C System (2016), 135 descendants of its own
- K172676: NuVasive® Modulus-C Interbody System (2017), 125 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own

## Indications for use
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The CoRoent Ti-C System is 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.

Source page: https://510kreport.com/device/K160916
Methodology: https://510kreport.com/methodology