# K081968: Modification to Lucent

- Pathway: 510(k) (Special)
- Applicant: Spinal Elements, Inc.
- Decided: Aug 5, 2008 after 26 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: 1 generation back to K071724 (2007). 2 ancestors in all.
716 later devices descend from it; 12 cite it directly.
1 of 719 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 2.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007) Summary page 2.

## Most influential descendants
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K141405: Mobis II ST Spinal Implant (2014), 461 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own

## Indications for use
When used as a vertebral body replacement: When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device: When used as an intervertebral body fusion device, the Lucent device is 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). This device is 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

Source page: https://510kreport.com/device/K081968
Methodology: https://510kreport.com/methodology