# K152011: Lucent Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jun 9, 2016 after 324 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: 13 generations back to K841189 (1984). 32 ancestors in all.
106 later devices descend from it; 6 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 4.
- K122967: Lucent, Spinal Elements, Inc. (2013) Summary page 4.
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K181837: Spinal Elements Ti-Bond coated devices (2018), 98 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 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 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 non-operative treatment prior to being treated with this device.

Source page: https://510kreport.com/device/K152011
Methodology: https://510kreport.com/methodology