# K160976: Altus Spine Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Jan 25, 2017 after 293 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: 15 generations back to K841189 (1984). 147 ancestors in all.
8 later devices descend from it; 4 cite it directly.
1 of 156 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.
- K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage, Camber Spine Technologies (2013) Summary page 4.
- K151140: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 4.
- K123207: Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System, Osteomed LP (2012) Summary page 4.
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System, Choicespine, LP (2016). Cleared while this submission was under review Summary page 4.
- K111553: Spinefrontier Lumbar Ibf System, Spinefrontier, Inc. (2011) Summary page 4.

## Most influential descendants
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 descendants of its own
- K171329: Altus Spine Titanium Interbody Fusion System (2017), 2 descendants of its own
- K182406: Altus Spine Interbody Fusion System (2019), 1 descendant of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- 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, such as the Altus Spine Pedicle Screw System.

Source page: https://510kreport.com/device/K160976
Methodology: https://510kreport.com/methodology