# K163670: Rampart One Lumbar Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: May 8, 2017 after 132 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). 175 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153082: Rampart A Lumbar Interbody Fusion Device, Spineology, Inc. (2016) Summary page 4.
- K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device, Spineology, Inc. (2011) Summary page 4.
- K160906: Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device, Spineology, Inc. (2016) Summary page 4.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 4.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 4.
- K163543: Biomet Fusion System, Zimmer Biomet Spine, Inc. (2017). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K180002: Rampart One Lumbar Interbody Fusion Device (2018), 2 descendants of its own
- K191091: Rampart One Lumbar Interbody Fusion System (2019), 1 descendant of its own
- K192047: Rampart™ One Lumbar Interbody Fusion System (2019), 0 descendants of its own

## Indications for use
The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K163670
Methodology: https://510kreport.com/methodology