# K162431: Luna 3D Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Nov 17, 2016 after 78 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: 18 generations back to K841189 (1984). 143 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 147 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 4.
- K142023: Luna Interbody System, Benvenue Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Luna 3D Interbody Fusion System consists of the Luna 3D 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 I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K162431
Methodology: https://510kreport.com/methodology