# K250773: Luna® Ti Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Feb 4, 2026 after 327 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: 28 generations back to K841189 (1984). 557 ancestors in all.
No later device cites it as a predicate yet.
1 of 558 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 6.
- K193172: Luna XD Ti Interbody Fusion System, Benvenue Medical, Inc. (2020) Summary page 6.
- K223412: LumiVy™ Lumbar IBF System, Vy Spine, LLC (2023) Summary page 6.
- K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L  NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System, SeaSpine Orthopedics Corporation (2020) Summary page 6.

## Indications for use
The Luna® Ti lnterbody Fusion System consists of a Luna Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DOD) at one or two contiguous levels from L2-S1. DOD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna Ti lnterbody 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 non-operative treatment prior to receiving the Luna Ti Implant. The Luna Ti lnterbody Fusion System is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K250773
Methodology: https://510kreport.com/methodology