# K142271: Zavation Z-Link Lumbar

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Dec 19, 2014 after 126 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 14 generations back to K841189 (1984). 66 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 5.
- K120576: Zavation Ibf System, Zavation, LLC (2012) Summary page 5.

## Most influential descendants
- K191339: Zavation eZspand Interbody System (2019), 5 descendants of its own
- K220581: Zavation eZspand Interbody System (2022), 4 descendants of its own
- K223174: X-Pac Expandable LLIF Cage System (2023), 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

## Indications for use
The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.

Source page: https://510kreport.com/device/K142271
Methodology: https://510kreport.com/methodology