# K233807: LumiVy™ Lumbar IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Sep 24, 2024 after 300 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: 25 generations back to K841189 (1984). 416 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 418 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 5.
- K223412: LumiVy™ Lumbar IBF System, Vy Spine, LLC (2023) Summary page 5.
- K212715: Vy Spine ClariVy Cervical IBF System, Vy Spine, LLC (2021) Summary page 5.
- K230414: ClariVy™ Cervical IBF System, Vy Spine, LLC (2023) Summary page 5.
- K231836: ClariVy™ Cervical IBF System, Vy Spine, LLC (2023) Summary page 5.
- K172343: Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology, Rti Surgical, Inc. (2017) Summary page 5.
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2020) Summary page 5.

## Most influential descendants
- K241783: FortiVy™ OsteoVy™ Lumbar IBF (2025), 0 descendants of its own

## Indications for use
The LumiVy™ 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 LumiVy™ 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. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation. Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted for cages with a lordosis of less than or equal to 20°.

Source page: https://510kreport.com/device/K233807
Methodology: https://510kreport.com/methodology