# K231486: Stable-L Standalone Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Oct 12, 2023 after 142 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: 26 generations back to K841189 (1984). 477 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 479 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212498: Stable-L Standalone Lumbar Interbody System, Nexus Spine, LLC (2022) Summary page 4.

## Most influential descendants
- K243934: Stable-L Lumbar Interbody System (2025), 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/K231486
Methodology: https://510kreport.com/methodology