# K234150: Lucent® XP

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements
- Decided: Mar 27, 2024 after 89 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 22 generations back to K841189 (1984). 204 ancestors in all.
No later device cites it as a predicate yet.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182584: Lucent® XP, Spinal Elements, Inc. (2018) Summary page 5.
- K202298: Lucent XP, Lucent XP Curved, Spinal Elements, Inc. (2020) Summary page 5.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 5.
- K113527: Opticage Interbody Fusion Device, Interventional Spine, Inc. (2012) Summary page 5.

## Indications for use
Lucent® XP intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2- S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Source page: https://510kreport.com/device/K234150
Methodology: https://510kreport.com/methodology