# K181621: Stable-C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Oct 19, 2018 after 121 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- 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). 334 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170297: Tranquil Interbody System, Nexus Spine, LLC (2017) Summary page 4.
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System, Genesys Spine (2018). Cleared while this submission was under review Summary page 4.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 4.
- K150765: LDR Spine ROI-C Cervical Cage System, Ldr Spine USA (2015) Summary page 4.
- K151934: ROI-C Titanium-Coated Implant System, Ldr Spine USA (2015) Summary page 4.
- K171489: Acapella Cervical Spacer System, Choicespine, LP (2017) Summary page 4.
- K122008: Incite Anchored Cervical Interbody (Aci) Fusion Device, Incite Innovation, LLC (2012) Summary page 4.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 4.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 4.
- K142079: Stalif Cti, Stalif C, Centinel Spine, Inc. (2014) Summary page 4.
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 4.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.
- K133218: Crystal ®; Mosaic ®; Vertu ®, Spinal Elements, Inc. (2014) Summary page 4.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 4.
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies (2016) Summary page 4.
- K170961: NuVasive CoRoent Small Interlock II System, Nu Vasive, Incorporated (2017) Summary page 4.
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 4.
- K111119: Trabecular Metal (TM) Fusion Device, Zimmer Spine, Inc. (2011) Summary page 4.

## Most influential descendants
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own
- K241467: Stable-C Interbody System (2024), 2 descendants of its own
- K261279: DeltaNEC Interbody System (2026), 0 descendants of its own

## Indications for use
The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K181621
Methodology: https://510kreport.com/methodology