# K223412: LumiVy™ Lumbar IBF System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: Jan 6, 2023 after 58 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: 22 generations back to K841189 (1984). 304 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 310 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212930: LumiVy Lumbar IBF System, Vy Spine, LLC (2022) Summary page 4.
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2020) Summary page 4.
- K193636: SeaSpine Reef TH System, SeaSpine Orthopedics Corporation (2020) Summary page 4.
- K192132: SeaSpine Beachside System, SeaSpine Orthopedics Corporation (2019) Summary page 4.
- K181079: SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K173606: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K173260: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene, Seaspine, Inc. (2014) Summary page 4.

## Most influential descendants
- K230414: ClariVy™ Cervical IBF System (2023), 3 descendants of its own
- K231836: ClariVy™ Cervical IBF System (2023), 2 descendants of its own
- K233807: LumiVy™ Lumbar IBF System (2024), 1 descendant of its own
- K250773: Luna® Ti Interbody Fusion System (2026), 0 descendants of its own
- K241783: FortiVy™ OsteoVy™ Lumbar IBF (2025), 0 descendants of its own

## Indications for use
The LumiVym Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The LumiVym Lumbar IBF System is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Additional supplemental fixation is not necessary for the LumiVyTM -AS implants if the integrated screws are implanted.

Source page: https://510kreport.com/device/K223412
Methodology: https://510kreport.com/methodology