# K221936: Standalone ALIF Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Oct 17, 2022 after 108 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 22 generations back to K841189 (1984). 293 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- K253260: ORIO-3D Cage System (2026), 0 descendants of its own
- K230851: Kodiak Lumbar Spacer System (2023), 0 descendants of its own

## Indications for use
The Eminent Spine Standalone ALIF Interbody Fusion System is 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 Eminent Spine Standalone ALIF Interbody Fusion System is a stand-alone interbody fusion device intended to be used with screws which accompany the spacers for fixation. Hyperlordotic implants (2:25 ° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I Spondylolisthesis or retrolisthesis. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K221936
Methodology: https://510kreport.com/methodology