# K211837: Altus Spine Interbody Standalone Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Apr 19, 2022 after 309 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 19 generations back to K841189 (1984). 345 ancestors in all.
No later device cites it as a predicate yet.
1 of 346 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K182406: Altus Spine Interbody Fusion System, Altus Partners, LLC (2019) Summary page 4.

## Indications for use
The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation. In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used. Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K211837
Methodology: https://510kreport.com/methodology