# K221162: UniVy OsteoVy Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Nov 4, 2022 after 196 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: 22 generations back to K841189 (1984). 276 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 279 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202266: Reliance Cervical IBF System, Reliance Medical Systems, LLC (2022) Summary page 4.
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 4.
- K212715: Vy Spine ClariVy Cervical IBF System, Vy Spine, LLC (2021) Summary page 4.

## Most influential descendants
- K223513: UniVy™ OsteoVy™-Ti Cervical IBF System (2023), 1 descendant of its own
- K241783: FortiVy™ OsteoVy™ Lumbar IBF (2025), 0 descendants of its own

## Indications for use
The UniVy™ OsteoVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 UniVy™ OsteoVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K221162
Methodology: https://510kreport.com/methodology