# K212498: Stable-L Standalone Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Mar 18, 2022 after 221 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: 25 generations back to K841189 (1984). 476 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 484 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203201: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System, Nu Vasive, Incorporated (2021) Summary page 4.
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 4.
- K181702: Tranquil-L Interbody System, Nexus Spine, LLC (2018) Summary page 4.
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System, Synthes USA Products, LLC (2016) Summary page 4.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 4.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 4.
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 4.

## Most influential descendants
- 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
- K231486: Stable-L Standalone Lumbar Interbody System (2023), 1 descendant of its own
- K261279: DeltaNEC Interbody System (2026), 0 descendants of its own

## Indications for use
The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

Source page: https://510kreport.com/device/K212498
Methodology: https://510kreport.com/methodology