# K133371: Rampart-L

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Jan 9, 2014 after 69 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: 6 generations back to K111880 (2011). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K131216: Rampart O, Spineology, Inc. (2013) Summary page 1.
- K132053: Rampart-O, Rampart-T, Spineology, Inc. (2013) Summary page 1.

## Cited in the summary but kept off the family tree
- K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device, Spineology, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K160074: Rampart D Lumbar Interbody Fusion Device (2016), 5 descendants of its own
- K171660: Duo Lumbar Interbody Fusion Device (2017), 4 descendants of its own
- K181792: Duo™ Lumbar Interbody Fusion Device (2018), 3 descendants of its own
- K182322: Duo Lumbar Interbody Fusion Device (2018), 2 descendants of its own
- K190055: Duo Lumbar Interbody Fusion Device (2019), 1 descendant of its own

## Indications for use
Rampart Tm L is an intervertebmil 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 madiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. RampartTM L 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/K133371
Methodology: https://510kreport.com/methodology