# K142023: Luna Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Nov 20, 2014 after 118 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: 12 generations back to K841189 (1984). 53 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130254: Prow Fusion, Nlt Spine, Ltd. (2013) Summary page 5.
- K092901: Epicage Interbody Fusion Device, R Tree Innovations (2010) Summary page 5.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 5.
- K122967: Lucent, Spinal Elements, Inc. (2013) Summary page 5.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 5.
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011) Summary page 5.
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 5.

## Most influential descendants
- K162431: Luna 3D Interbody Fusion System (2016), 3 descendants of its own
- K183560: Luna 3D GEN2 Interbody Fusion System (2019), 2 descendants of its own
- K193172: Luna XD Ti Interbody Fusion System (2020), 1 descendant of its own
- K250773: Luna® Ti Interbody Fusion System (2026), 0 descendants of its own
- K172019: Brisbane ALIF Device, Gladstone ALIF Device (2017), 0 descendants of its own

## Indications for use
The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant, The Luna 360 Interbody Fusion System is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K142023
Methodology: https://510kreport.com/methodology