# K083626: Distractable Wave Cage

- Pathway: 510(k) (Special)
- Applicant: Advanced Medical Technology, Inc.
- Decided: Oct 19, 2009 after 315 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
No predicates in its family tree.
660 later devices descend from it; 9 cite it directly.
1 of 661 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112316: 4-Web Alif Spinal Truss System (STS) (2011), 537 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K103111: Forza Spacer System (2011), 343 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own

## Indications for use
The distractable WAVE PLIF Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K083626
Methodology: https://510kreport.com/methodology