# K121330: Wave O Cage

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Technologies AG
- Decided: Jun 29, 2012 after 57 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: 1 generation back to K083626 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 1.

## Most influential descendants
- K212050: NGM WAVE PLIF Cage (2021), 0 descendants of its own

## Indications for use
The WAVE 0 Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolishesis or retrolisthesis at the involved levels. ODD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K121330
Methodology: https://510kreport.com/methodology