# K110933: Spineology Peek Lumbar Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Jun 13, 2011 after 70 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.
185 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) Pivotec Lumbar Interbody Fusion Device, Captiva Spine, 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
- 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
- K121129: Spineology Peek Lumbar Interbody Fusion Device (2012), 180 descendants of its own

## Indications for use
The Spineology PEEK Lumbar ihterbody Fusion Device is an intervertebral body fusion device indicated for interverfrbral body fuision 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 via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate 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/K110933
Methodology: https://510kreport.com/methodology