# K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 30, 2011 after 218 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 38 ancestors in all.
112 later devices descend from it; 3 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093808: Incite Innovation Stand Alone Interbody Fusion Device, Incite Innovation, LLC (2010) Summary page 2.
- K080572: LDR Spine Roi-a Implant, Ldr Spine USA (2008) Summary page 2.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 2.
- K090782: Novel Alif Spinal Spacer System, Alphatec Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Recalls of this device
- Mar 19, 2012 · Not classified · Z-1676-2012: Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fif

## Indications for use
The 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-S1 with up to Grade 1 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 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/K102402
Methodology: https://510kreport.com/methodology