# K182406: Altus Spine Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Feb 22, 2019 after 171 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: 18 generations back to K841189 (1984). 152 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 154 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073502: Vertebron VBR System, Vertebron, Inc. (2008) Summary page 4.
- K160976: Altus Spine Interbody Fusion System, Altus Partners, LLC (2017) Summary page 4.
- K171329: Altus Spine Titanium Interbody Fusion System, Altus Partners, LLC (2017) Summary page 4.

## Cited in the summary but kept off the family tree
- K141358: Cellvizio 100 Series with System Confocal Miniprobes, Mauna Kea Technologies (2014). Our reading of the summary gave K141358, FDA’s number for Cellvizio 100 Series with System Confocal Miniprobes (Mauna Kea Technologies). Its FDA name has none of the distinctive words the summary uses for the device it names, “Xenco Medical Set-X Hyperlordotic Implant”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K211837: Altus Spine Interbody Standalone Fusion System (2022), 0 descendants of its own

## Indications for use
The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems.

Source page: https://510kreport.com/device/K182406
Methodology: https://510kreport.com/methodology