# K220610: SOLO-L

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine, Inc.
- Decided: May 27, 2022 after 85 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: 23 generations back to K841189 (1984). 384 ancestors in all.
No later device cites it as a predicate yet.
1 of 385 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201671: A-Link Z, Acuity Surgical Devices, LLC (2021) Summary page 4.

## Indications for use
SOLO-Lis indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. SOLO-Lis intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to Sl, 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. SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

Source page: https://510kreport.com/device/K220610
Methodology: https://510kreport.com/methodology