# K123993: Solus Anterior Lumbar Interbody Fusion (Alif) System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 5, 2013 after 69 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: 9 generations back to K841189 (1984). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System, Alphatec Spine, Inc. (2011) Summary page 1.

## Indications for use
The Alphatec Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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 Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

Source page: https://510kreport.com/device/K123993
Methodology: https://510kreport.com/methodology