# K122967: Lucent

- Pathway: 510(k) (Special)
- Applicant: Spinal Elements, Inc.
- Decided: Feb 21, 2013 after 149 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: 3 generations back to P980048 (2001). 7 ancestors in all.
615 later devices descend from it; 9 cite it directly.
1 of 623 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 1.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007) Summary page 1.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 1.

## Most influential descendants
- K140319: Coroent TI-C System (2014), 590 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
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
Lucent 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 discogenie 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-fusibn 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 non-operative treatment prior to being treated with this device.

Source page: https://510kreport.com/device/K122967
Methodology: https://510kreport.com/methodology