# K203254: Lucent 3D Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Mar 26, 2021 after 142 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: 5 generations back to P980048 (2001). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 5.
- K150395: Omega LIF System, Amendia, Inc. (2015) Summary page 5.

## Most influential descendants
- K222833: Ventana™ C Spinal System (2023), 4 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
- K231252: Ventana™ L Spinal System (2023), 1 descendant of its own
- K261279: DeltaNEC Interbody System (2026), 0 descendants of its own

## Indications for use
Lucent® 3D 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 corticocancellous 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/K203254
Methodology: https://510kreport.com/methodology