# K152620: Spine Wave Gen II Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jan 15, 2016 after 123 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: 16 generations back to K841189 (1984). 65 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131071: Staxx Ibl System, Spine Wave, Inc. (2013) Summary page 5.
- K132719: Staxx Ibl System, Spine Wave, Inc. (2013) Summary page 5.
- K123461: Staxx (R) IB System, Spine Wave, Inc. (2013) Summary page 5.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 5.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 5.
- K113285: LDR Spine Usa Avenue L Interbody Fusion, Ldr Spine USA, Inc. (2012) Summary page 5.
- K103814: Pezo Interbody Cages System, Ulrich GmbH & Co. KG (2011) Summary page 5.
- K140007: Abacus TM Spacer System, Spine Wave, Inc. (2014) Summary page 5.
- K141791: Biomet Fusion System, Biomet Spine (2014) Summary page 5.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 5.

## Most influential descendants
- K162760: Spine Wave Anterior Cervical Spine System (2017), 1 descendant of its own
- K173175: Paramount Anterior Cervical Cage System (2017), 0 descendants of its own

## Indications for use
The Spine Wave Gen Il Expandable Interbody 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 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. 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 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/K152620
Methodology: https://510kreport.com/methodology