# K073348: Lucent Magnum

- Pathway: 510(k) (Special)
- Applicant: Spinal Elements, Inc.
- Decided: Dec 26, 2007 after 27 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
No predicates in its family tree.
1,021 later devices descend from it; 8 cite it directly.
1 of 1,022 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own
- K081968: Modification to Lucent (2008), 716 descendants of its own
- K080822: VU Apod Intervertabral Body Fusion Device (2008), 708 descendants of its own
- K110632: Lucent or Lucent Magnum (2012), 694 descendants of its own
- K122967: Lucent (2013), 615 descendants of its own

## Indications for use
When used as a vertebral body replacement: When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (TL-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 intervertebralbody fusion device: When used as an intervertebral body fusion device, the Lucent Magnum device is intended for spinal fusion procedures at one or two contiguous levels (L2-SL) 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/K073348
Methodology: https://510kreport.com/methodology