# K100945: Fuse Plif Cafe

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Technologies AG
- Decided: Feb 9, 2011 after 309 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: 10 generations back to K841189 (1984). 27 ancestors in all.
463 later devices descend from it; 3 cite it directly.
0 of 491 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (2008) Summary page 1.

## Most influential descendants
- K150481: Cascadia Interbody System (2015), 459 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
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own

## Indications for use
The FUSE Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). FUSE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The FUSE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K100945
Methodology: https://510kreport.com/methodology