# K193172: Luna XD Ti Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Jul 2, 2020 after 230 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: 20 generations back to K841189 (1984). 153 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 155 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183560: Luna 3D GEN2 Interbody Fusion System, Benvenue Medical, Inc. (2019) Summary page 4.
- K150152: The Octane Straight Intervertebral Fusion Device, Ti Coated, Exactech, Inc. (2015) Summary page 4.

## Most influential descendants
- K250773: Luna® Ti Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti 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 XD Ti 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 XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K193172
Methodology: https://510kreport.com/methodology