# K243934: Stable-L Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Apr 30, 2025 after 131 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: 29 generations back to K841189 (1984). 727 ancestors in all.
No later device cites it as a predicate yet.
1 of 728 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231486: Stable-L Standalone Lumbar Interbody System, Nexus Spine, LLC (2023) Summary page 5.
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System, Nexus Spine, LLC (2023) Summary page 5.
- K241467: Stable-C Interbody System, Nexus Spine, LLC (2024) Summary page 6.
- K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA), 4Web Medical, Inc. (2024) Summary page 6.

## Indications for use
The Stable-L 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. When used with the provided blades, supplemental fixation is required. When used with the provided screws, 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/K243934
Methodology: https://510kreport.com/methodology