# K172484: A-CIFT SoloFuse

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: May 8, 2018 after 264 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- 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: 13 generations back to K841189 (1984). 42 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151198: A-CIFT SoloFuse, Spinefrontier, Inc. (2015) Summary page 5.
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device, Spinefrontier, Inc. (2014) Summary page 5.

## Most influential descendants
- K222004: INTEGRATE -C Interbody Fusion System (2023), 6 descendants of its own
- K232150: ZSFab Cervical Interbody System (2023), 4 descendants of its own
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (2024), 3 descendants of its own
- K252610: ZSFab Lumbar Interbody System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Recalls of this device
- Jun 13, 2019 · Class II · Z-1973-2019: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

## Indications for use
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

Source page: https://510kreport.com/device/K172484
Methodology: https://510kreport.com/methodology