# K261408: SABER-XA System

- Pathway: 510(k) (Traditional)
- Applicant: Elevation Spine
- Decided: Aug 3, 2026 after 95 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: 25 generations back to K841189 (1984). 455 ancestors in all.
No later device cites it as a predicate yet.
1 of 456 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 6.

## Indications for use
The Elevation Spine SABER-XA System is indicated for intervertebral fusion in patients with DDD at one or two contiguous levels from L1 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SABER-XA Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The Elevation Spine SABER-XA Anterior Lumbar Plate, when used with screws and without the SABER-XA spacer component, is intended for anterior screw fixation to the lumbosacral spine (L1-S1) to treat instability resulting from: fracture (including dislocation and subluxation), tumor, degenerative disc disease (as defined above), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The Anterior Lumbar Plate is not to be used alone with Spikes, but may be used in construct with the spacer and spikes. All interbody fusion constructs of SABER-XA System are intended to be used with FDA cleared supplemental fixation.

Source page: https://510kreport.com/device/K261408
Methodology: https://510kreport.com/methodology