# K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Sep 26, 2011 after 87 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
No predicates in its family tree.
186 later devices descend from it; 7 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)
- None. The FDA summary names its predicate without a number.
- (no number) 4CIS® PEEK PLIF Cage System from Solco, USA, Inc.: named in the summary without a submission number
- (no number) Capstone Spinal System, Medtronic Sofamor Danek: named in the summary without a submission number

## Most influential descendants
- K113030: Spineology Peek Bullet Lumbar Interbody Fusion Device (2012), 185 descendants of its own
- K120293: Spineology Peek Lumbar Interbody Fusion Drive (2012), 184 descendants of its own
- K130396: Rampart O and Rampart P (2013), 181 descendants of its own
- K123652: Spineology Peek Lumbar Interbody Fusion Device (2013), 181 descendants of its own
- K131216: Rampart O (2013), 180 descendants of its own

## Indications for use
The Spineology PEEK Bullet Lumbar Interbody Fusion Device 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 transfoaraminal approach. The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with Supplemental fixation systems Ccared, by the FDA fior use in the lumbar spine.

Source page: https://510kreport.com/device/K111880
Methodology: https://510kreport.com/methodology