# K121129: Spineology Peek Lumbar Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Jun 13, 2012 after 61 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.
180 later devices descend from it; 2 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120293: Spineology Peek Lumbar Interbody Fusion Drive, Spineology, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own

## Indications for use
The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebraJ body fusion device indicated for intervertebral body fuision at one level or two contiguous levels in the lumbar spine from L2 to SIt 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/K121129
Methodology: https://510kreport.com/methodology