# K223513: UniVy™ OsteoVy™-Ti Cervical IBF System

- Pathway: 510(k) (Special)
- Applicant: Vy Spine, LLC
- Decided: Apr 18, 2023 after 147 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: 30 generations back to K841189 (1984). 943 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 945 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221162: UniVy OsteoVy Cervical IBF System, Vy Spine, LLC (2022) Summary page 4.
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System, Alphatec Spine, Inc. (2022) Summary page 4.

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

## Indications for use
The UniVy™ OsteoVy™.-Ti 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™.-Ti 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™-Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K223513
Methodology: https://510kreport.com/methodology