# K180076: Ti 3Z Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Jul 27, 2018 after 198 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: 19 generations back to K841189 (1984). 145 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112664: Zavation Ibf Systems, Zavation, LLC (2011) Summary page 5.
- K152304: Tritanium PL Cage, Stryker (2015) Summary page 5.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 5.

## Most influential descendants
- K212811: Ti3Z Lumbar Interbody System (2022), 3 descendants of its own
- K230731: Zavation ALIF System (2023), 2 descendants of its own
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (2024), 1 descendant of its own
- K250769: Dakota LP System (2025), 0 descendants of its own

## Indications for use
When used as a lumbar intervertebral body fusion device, the Zavation Ti 3Z Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are 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 I 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 intended to be used in patients who have had six months of non-operative treatment. For all the above indications the Zavation Ti 3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.

Source page: https://510kreport.com/device/K180076
Methodology: https://510kreport.com/methodology