# K190193: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

- Pathway: 510(k) (Special)
- Applicant: Spineex, Inc.
- Decided: Mar 4, 2019 after 28 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: 16 generations back to K841189 (1984). 104 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181531: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices, Spineex, Inc. (2018) Summary page 4.

## Most influential descendants
- K200816: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (2020), 1 descendant of its own
- K223065: Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices (2022), 0 descendants of its own

## Indications for use
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K190193
Methodology: https://510kreport.com/methodology