# K181030: Rubicon Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Rubicon Spine, LLC
- Decided: Jul 17, 2018 after 90 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: 16 generations back to K841189 (1984). 100 ancestors in all.
No later device cites it as a predicate yet.
1 of 101 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151819: Integrity Spine Lumbar Interbody Fusion System, Integrity Spine Lumbar Interbody Fusion System (2015) Summary page 5.
- K073502: Vertebron VBR System, Vertebron, Inc. (2008) Summary page 5.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 5.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 5.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 5.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 5.
- K101051: Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX, Stryker Spine (2010) Summary page 5.
- K141443: Infront Lumbar Interbody Fusion System, Infront Medical, LLC (2014) Summary page 5.

## Indications for use
The Rubicon Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Source page: https://510kreport.com/device/K181030
Methodology: https://510kreport.com/methodology