# K230219: Eminent Spine 3D Lumbar Interbody Fusion Systems

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine, LLC
- Decided: May 16, 2023 after 110 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: 9 generations back to K841189 (1984). 34 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.
- K212701: Eminent Spine 3D Cervical Interbody Fusion System, Eminent Spine (2023). Cleared while this submission was under review Summary page 4.
- K190364: CancelleX Porous Titanium Lumbar Interbody Device, Xenco Medical, LLC (2019) Summary page 4.

## Most influential descendants
- K243074: Spectrum Spine Lumbar Cage System (2025), 2 descendants of its own
- K253260: ORIO-3D Cage System (2026), 0 descendants of its own
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (2026), 0 descendants of its own
- K253377: Expandable Titanium PLIF/TLIF System (2025), 0 descendants of its own

## Indications for use
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K230219
Methodology: https://510kreport.com/methodology