# K170553: Altus Spine Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Dec 1, 2017 after 280 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). 148 ancestors in all.
No later device cites it as a predicate yet.
1 of 149 devices in its family (counting itself) has a Class I recall.

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

## 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, such as the Altus Spine Pedicle Screw System.

Source page: https://510kreport.com/device/K170553
Methodology: https://510kreport.com/methodology