# K241783: FortiVy™ OsteoVy™ Lumbar IBF

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Mar 18, 2025 after 271 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: 31 generations back to K841189 (1984). 1,023 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,024 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233807: LumiVy™ Lumbar IBF System, Vy Spine, LLC (2024). Cleared while this submission was under review Summary page 5.
- K223513: UniVy™ OsteoVy™-Ti Cervical IBF System, Vy Spine, LLC (2023) Summary page 5.
- K183049: Reliance Lumbar IBF System, Reliance Medical Systems, LLC (2019) Summary page 5.
- K193370: Nexxt Matrixx System, Nexxt Spine, LLC (2020) Summary page 5.

## Indications for use
The FortiVy™ OsteoVy™ 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 FortiVy™ OsteoVy™ 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.

Source page: https://510kreport.com/device/K241783
Methodology: https://510kreport.com/methodology