# K253559: Ventana™ A Anterior Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Feb 25, 2026 after 100 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: 21 generations back to K841189 (1984). 245 ancestors in all.
No later device cites it as a predicate yet.
1 of 246 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132596: Proposed Optimus, Custom Spine, Inc. (2014) Summary page 5.
- K231252: Ventana™ L Spinal System, Spinal Elements, Inc. (2023) Summary page 5.
- K170235: Lucent®, Spinal Elements, Inc. (2017) Summary page 5.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 5.
- K200429: BEE Cages, NGMedical GmbH (2021) Summary page 5.

## Indications for use
The Ventana® A Anterior Lumbar Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Ventana® A Anterior Lumbar System is intended for patients who have had at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Ventana® A Anterior Lumbar Interbody System may be used as a standalone device when used with three integrated fixation screws and has a lordotic angle of 20° or less. When an interbody device with fewer than three screws is used, supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

Source page: https://510kreport.com/device/K253559
Methodology: https://510kreport.com/methodology