# K182195: Arco™-SA Lumbar Cage System

- Pathway: 510(k) (Special)
- Applicant: Neurostructures, Inc.
- Decided: Nov 9, 2018 after 87 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: 20 generations back to K841189 (1984). 278 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 282 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173082: Arco™-SA Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K161129: Pillar SA PTC, Orthofix, Inc. (2016) Summary page 5.

## Most influential descendants
- K200541: Hive™ Stand-alone Anterior Lumbar Interbody System (2020), 1 descendant of its own
- K202820: Australis Anterior Lumbar Cage System (2020), 0 descendants of its own
- K202190: Oculus-SA Lumbar Cage System (2020), 0 descendants of its own

## Indications for use
The Arco™-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) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous 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 fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody 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/K182195
Methodology: https://510kreport.com/methodology