# K261020: Symmetrix™ L Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jul 14, 2026 after 109 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: 33 generations back to K841189 (1984). 1,405 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K242364: IdentiTi™ II Interbody System, Alphatec Spine, Inc. (2024) Summary page 5.

## Indications for use
The Symmetrix™ L Spinal System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, spinal stenosis, failed previous fusion (pseudarthrosis), and/or disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two contiguous levels. Additionally, the Symmetrix™ L Spinal System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients should have had six months of nonoperative treatment prior to treatment with this device. The Symmetrix™ L Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, demineralized allograft bone with bone marrow aspirate, and/or bone void filler cleared for use within the intervertebral body space to facilitate fusion. The Symmetrix™ L Spinal System is intended to be used with supplemental fixation cleared for use in the thoracic and/or lumbar spine.

Source page: https://510kreport.com/device/K261020
Methodology: https://510kreport.com/methodology