# K191354: Ti3Z Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Sep 9, 2019 after 111 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). 266 ancestors in all.
13 later devices descend from it; 3 cite it directly.
1 of 280 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181246: Zavation IBF System, Zavation Medical Products, LLC (2018) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- K172941: CASCADIA Interbody System, K2m (2018) Summary page 5.

## Most influential descendants
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K212811: Ti3Z Lumbar Interbody System (2022), 3 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.

Source page: https://510kreport.com/device/K191354
Methodology: https://510kreport.com/methodology