# K131216: Rampart O

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: May 30, 2013 after 30 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: 4 generations back to K111880 (2011). 6 ancestors in all.
180 later devices descend from it; 2 cite it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device, Spineology, Inc. (2011)
- K113030: Spineology Peek Bullet Lumbar Interbody Fusion Device, Spineology, Inc. (2012) Summary page 1.
- K120293: Spineology Peek Lumbar Interbody Fusion Drive, Spineology, Inc. (2012) Summary page 1.
- K123652: Spineology Peek Lumbar Interbody Fusion Device, Spineology, Inc. (2013) Summary page 1.
- K130396: Rampart O and Rampart P, Spineology, Inc. (2013) Summary page 1.

## Most influential descendants
- K132053: Rampart-O, Rampart-T (2013), 179 descendants of its own
- K171031: CRESCENT™ Spinal System (2017), 144 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own

## Indications for use
Rampart™ 0 is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI 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 of non-operative treatment. These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach. Rampart™ 0 is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K131216
Methodology: https://510kreport.com/methodology