# K112561: Nuvasive Coroent NO-Profile System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Mar 13, 2012 after 193 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: 13 generations back to K841189 (1984). 71 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 1.
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System, Spine Smith Partners L.P. (2010) Summary page 1.
- K041617: Stalif TT, Surgicraft, Ltd. (2004) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.
- K091301: Life Spine Stand-Alone Spacer System, Life Spine (2009) Summary page 1.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (2016), 11 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System (2023), 2 descendants of its own

## Indications for use
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) 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. ODD 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 No-Profile 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 No-Profile System.

Source page: https://510kreport.com/device/K112561
Methodology: https://510kreport.com/methodology