# K142392: Zavation Posterior LEIF

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Apr 29, 2015 after 245 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: 14 generations back to K841189 (1984). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120576: Zavation Ibf System, Zavation, LLC (2012) Summary page 5.
- K110226: Interfuse T Invertebral Body Fusion Device, Vertebral Technologies, Inc. (2011) Summary page 5.

## Indications for use
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF 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 device is intended to be used in patients who have had six months of non-operative treatment. The Zavation Posterior LEIF 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/K142392
Methodology: https://510kreport.com/methodology