# K132053: Rampart-O, Rampart-T

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Sep 16, 2013 after 75 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: 5 generations back to K111880 (2011). 8 ancestors in all.
179 later devices descend from it; 5 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131216: Rampart O, Spineology, Inc. (2013) Summary page 1.
- K121129: Spineology Peek Lumbar Interbody Fusion Device, Spineology, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own

## Indications for use
Rampart 0: 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. Rampaa 0 is designed for use with autografi as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pediele screws) cleared by the FDA for use in the lumbar spine. Rampart T: Rampart T 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. Rampart T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K132053
Methodology: https://510kreport.com/methodology