# K123652: Spineology Peek Lumbar Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Mar 22, 2013 after 115 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: 3 generations back to K111880 (2011). 4 ancestors in all.
181 later devices descend from it; 3 cite it directly.
0 of 186 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) Summary page 1.
- K113030: Spineology Peek Bullet Lumbar Interbody Fusion Device, Spineology, Inc. (2012)
- K120293: Spineology Peek Lumbar Interbody Fusion Drive, Spineology, Inc. (2012) Summary page 1.

## Most influential descendants
- K131216: Rampart O (2013), 180 descendants of its own
- 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

## Indications for use
Rampart 0 and Rampart P are 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 and Rampart P are 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/K123652
Methodology: https://510kreport.com/methodology