# K191091: Rampart One Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: May 23, 2019 after 29 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). 216 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180002: Rampart One Lumbar Interbody Fusion Device, Spineology, Inc. (2018) Summary page 4.

## Most influential descendants
- 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. The standard Rampart One device may be used with or without supplemental fixation using fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws. The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K191091
Methodology: https://510kreport.com/methodology