# K160291: Optimus ALIF System

- Pathway: 510(k) (Special)
- Applicant: Amendia, Inc.
- Decided: Feb 18, 2016 after 15 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: 14 generations back to K841189 (1984). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132596: Proposed Optimus, Custom Spine, Inc. (2014) Summary page 4.

## Indications for use
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment. The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

Source page: https://510kreport.com/device/K160291
Methodology: https://510kreport.com/methodology