# K161993: Leva® Anterior Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Nov 22, 2016 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: 16 generations back to K841189 (1984). 151 ancestors in all.
No later device cites it as a predicate yet.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082926: Zuma, Model 55-XXXX/56-XXXX, Seaspine, Inc. (2008) Summary page 4.
- K130445: Vault Alif System, Spinal USA (2013) Summary page 4.
- K122168: Visualif Challenging Access Plate, Spine Smith Partners L.P. (2012) Summary page 4.
- K120101: Independence Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K133947: Irix-a Lumbar Integrated Fusion System, X-Spine Systems, Inc. (2014) Summary page 4.
- K142487: Chesapeake Stabilization System, K2m, Inc. (2015) Summary page 4.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 4.

## Indications for use
The Leva® Anterior Interbody System is a stand-alone system indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Anterior Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K161993
Methodology: https://510kreport.com/methodology