# K230414: ClariVy™ Cervical IBF System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: May 12, 2023 after 85 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 23 generations back to K841189 (1984). 357 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212715: Vy Spine ClariVy Cervical IBF System, Vy Spine, LLC (2021) Summary page 4.
- K223412: LumiVy™ Lumbar IBF System, Vy Spine, LLC (2023) Summary page 4.

## Most influential descendants
- K231836: ClariVy™ Cervical IBF System (2023), 2 descendants of its own
- K233807: LumiVy™ Lumbar IBF System (2024), 1 descendant of its own
- K241783: FortiVy™ OsteoVy™ Lumbar IBF (2025), 0 descendants of its own

## Indications for use
The ClariVy™ Cervical 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. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.

Source page: https://510kreport.com/device/K230414
Methodology: https://510kreport.com/methodology