# K202190: Oculus-SA Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures
- Decided: Oct 2, 2020 after 58 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: 21 generations back to K841189 (1984). 295 ancestors in all.
No later device cites it as a predicate yet.
1 of 296 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182195: Arco™-SA Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K173082: Arco™-SA Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System, Corelink, LLC (2018) Summary page 5.
- K161129: Pillar SA PTC, Orthofix, Inc. (2016) Summary page 5.
- K130445: Vault Alif System, Spinal USA (2013) Summary page 5.

## Indications for use
The Oculus-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA. The Oculus-SA Lumbar Cage System implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

Source page: https://510kreport.com/device/K202190
Methodology: https://510kreport.com/methodology