# K153222: Leva Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 15, 2016 after 161 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: 4 generations back to P950019 (1996). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151581: Leva Spacer System, Spine Wave, Inc. (2015) Summary page 4.

## Most influential descendants
- K231275: Exceed™ Biplanar Expandable Interbody System (2023), 2 descendants of its own
- K162760: Spine Wave Anterior Cervical Spine System (2017), 1 descendant of its own
- K261159: Exceed® Biplanar Expandable Interbody System (2026), 0 descendants of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own
- K173175: Paramount Anterior Cervical Cage System (2017), 0 descendants of its own

## Indications for use
The Leva® Spacer System is 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® Spacer System is to be used with autogenous bone graft and with supplemental fixation. 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/K153222
Methodology: https://510kreport.com/methodology