# K191339: Zavation eZspand Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Aug 19, 2019 after 91 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: 20 generations back to K841189 (1984). 185 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172696: FORZA® XP Expandable Spacer System, Orthofix, Inc. (2018) Summary page 5.
- K181246: Zavation IBF System, Zavation Medical Products, LLC (2018) Summary page 5.
- K142271: Zavation Z-Link Lumbar, Zavation, LLC (2014) Summary page 5.

## Most influential descendants
- K220581: Zavation eZspand Interbody System (2022), 4 descendants of its own
- K223174: X-Pac Expandable LLIF Cage System (2023), 3 descendants of its own
- K251003: X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own
- K251617: X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own
- K250602: X-PAC® N-GAGE™ Lumbar Plate System (2025), 0 descendants of its own

## Indications for use
The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand PLIF 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. The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.

Source page: https://510kreport.com/device/K191339
Methodology: https://510kreport.com/methodology